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Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CAROTID, Model Number: DYNJ54287A; b. CAROTID PACK, Model Number: DYNJ66190; c. CAROTID SUPPLY, Model Number: DYNJ905622C; d. CAROTID-LF, Model Number: DYNJ901745J; e. CENTRAL LINE INSERTION, Model Number: DYNJ63347A; f. CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069G; g. DBD-CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069I; h. DBD-IR THYROID PACK THLUF642-LF, Model Number: DYNJ47716B; i. ENT FREE FLAP, Model Number: SYNJ910018A; j. ENT FREE FLAP PACK, Model Number: DYNJ67954A; k. FEM CAROTID PACK, Model Number: DYNJ65706; l. FLAP ENT FREE, Model Number: DYNJ905340A; m. FREE FLAP PACK-LF, Model Number: DYNJ20495J; n. PACK HEAD NECK, Model Number: DYNJ30245; o. SVMMC CAROTID PACK, Model Number: DYNJ43861D; p. TAVR FAIRFAX, Model Number: DYNJ63634A; q. VNUS TRAY, Model Number: DYNJ44410F;

MEDLINE INDUSTRIES, LP - Northfield

🏥 Medical Devices Class I - Dangerous

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

May 15, 2023 Other Medical Devices Nationwide View Details →

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. AAA PACK, Model Number: DYNJ44847I; b. ABDOMINAL VASCULAR PACK, Model Number: DYNJ82578; c. ABDOMINAL VASCULAR-LF, Model Numbers: DYNJ905291B, DYNJ905291C; d. ABLATION PACK, Model Number: DYNJ61957A; e. ACCESSORY OPEN HEART PACK, Model Number: DYNJ36600F; f. ADULT CORONARY PACK, Model Numbers: DYNJV0275J, DYNJV0275K, DYNJV0275L, DYNJV0275M; g. AFIB PACK, Model Number: DYNJ69682; h. ALT MINOR VASCULAR CDS, Model Number: CDS840493F; i. ANGIO-VASCULAR, Model Number: DYNJ24272C; j. ARM VASCULAR-LF, Model Number: DYNJ905290D; k. ARTERIAL/VENOUS ACCESS TRAY, Model Number: DYNDC3038; l. ARTERIOGRAM PACK, Model Numbers: DYNJ81636, DYNJ81636A; m. ARTERIOGRAM PACK 2, Model Number: DYNJ83051; n. AUD MAJOR VASC PK-LF, Model Number: DYNJ40728D; o. AUD MAJOR VASCULAR-LF, Model Number: DYNJ40728A, DYNJ40728B, DYNJ40728C; p. AV FIST PACK, Model Number: DYNJ83462; q. AV FISTULA, Model Numbers: DYNJ64143B, DYNJ905219B, DYNJ905219C, DYNJ905219D; DYNJ905219F, DYNJ906341D, DYNJ906945A, DYNJ907975, DYNJ907975B, DYNJ908096; r. AV FISTULA CAROTID PACK, Model Number: DYNJ82570; s. AV FISTULA PACK, Model Number: DYNJ52093J, DYNJ62218B, DYNJ66184A, DYNJ66184B, DYNJ67178A, DYNJ69443A, DYNJ69443B, DYNJ69443D, DYNJ69489A, DYNJ81033, DYNJ81605, DYNJ82477; t. AV FISTULA PACK-LF, Model Number: DYNJ64499B, DYNJ64499D, DYNJ69167A, DYNJ69167C; u. AV FISTULA VASCULAR, Model Number: DYNJ67340; v. AV GRAFT, Model Number: DYNJ903457D; w. AV GRAFT-LF, Model Number: DYNJ40077F; x. BAPTIST SOUTH OPEN HEART CV PK, Model Number: CDS983147F, CDS983147I; y. BEDSIDE PICC CDS, Model Number: CDS984642; z. BGMC CAROTID MAJOR VASCULAR, Model Number: DYNJ907339; aa. C V MAJOR PACK, Model Number: DYNJ64861A; bb. C V MINOR PACK, Model Number: DYNJ64862B; cc. CABG, Model Numbers: DYNJ906878A, DYNJ9372030F, DYNJ9372030G; dd. CABG HEART CDS, Model Number: CDS985384C; ee. CABG PACK, Model Numbers: DYNJ0408782AA, DYNJ53827, DYNJ59036B, DYNJ59036C, DYNJ59036D, DYNJ59036F; ff. CABG PACK NTX, Model Numbers: DYNJ68389, DYNJ68389A; gg. CARDIAC A B PACK-LF, Model Number: DYNJV0177AG; hh. CARDIAC A & B PACK-LF, Model Number: DYNJV0177AG; ii. CARDIAC CABG B, Model Numbers: DYNJ908121A, DYNJ908121B; jj. CARDIAC CABG PACK, Model Number: DYNJ903072R; kk. CARDIAC CATH PACK, Model Number: DYNJ41195D; ll. CARDIAC EP PACK-LF, Model Numbers: DYNJ0429185K, DYNJ0429185M; mm. CARDIAC ROBOT PACK, Model Number: DYNJ66254A; nn. CARDIOLOGY EP, Model Number: DYNJ59968; oo. CARDIOVASCULAR PT 2, Model Numbers: DYNJ905516C, DYNJ905516D, DYNJ905516F; pp. CAROTID DR WILLIAMS, Model Numbers: DYNJ906351B, DYNJ906351D; qq. CAROTID ENDARTERECTOMY, Model Number: DYNJ905640A; rr. CAROTID PACK, Model Numbers: DYNJ0810062AI, DYNJ0810062AJ, DYNJ39488G, DYNJ66190A, DYNJ66190B, DYNJ66190C, DYNJ80346A; ss. CAROTID PACK-LF, Model Number: DYNJ57646C; tt. CAROTID SUPPLY PACK, Model Number: DYNJ81369; uu. CAROTID VASCULAR PACK, Model Number: DYNJ44927F; vv. CAROTID-LF, Model Number: CDS984764F, DYNJ901745K; ww. CATH LAB PACK, Model Number: DYNJ57735F; xx. CATH PACK, Model Number: DYNJ59830A; yy. CLOVIS CATH LAB PACK, Model Number: DYNJ62379A; zz. CT CABG-LF - IFCAP 7279, Model Number: DYNJC9258G; aaa. CUH OPEN HEART A B C - CDS, Model Number: CDS983202F, CDS983202G, CDS983202I; bbb. CUSTOM CARDIAC CABG, Model Number: DYNJ906108A, DYNJ906108B, DYNJ906108C; ccc. CV AAA PACK W AUX, Model Number: DYNJ65710A; ddd. CV CDS, Model Number: CDS985395D; eee. CVOR ANGIOGRAPHY PACK, Model Number: DYNJ83432; fff. CVOR ENDOVASCULAR PACK, Model Number: DYNJ64506A; ggg. CVP PACK, Model Numbers: DYNJ46359C, DYNJ46359D; hhh. DBD-ABDOMINAL VASCULAR-LF, Model Number: DYNJ905291C; iii. DBD-ALT MINOR VASCULAR CDS, Model Number: CDS840493F; jjj. DBD-ALT MINOR VASCULAR CDS, Model Number: CDS840493F; kkk. DBD-AV FISTUL

MEDLINE INDUSTRIES, LP - Northfield

🏥 Medical Devices Class I - Dangerous

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

May 15, 2023 Other Medical Devices Nationwide View Details →

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. FETAL INTERVENTION, Model Number: DYNJ66041A, DYNJ66041B; b. FETAL INTERVENTION PACK, Model Number: DYNJ62319A, DYNJ62319B; c. ULTRASOUND PIV KIT, Model Number: DYNDV2397; d. VAD ACCESS, Model Number: DYNJ24276C; e. VAGINAL DELIVERY TRAY, Model Number: DYNJ27275

MEDLINE INDUSTRIES, LP - Northfield

🏥 Medical Devices Class I - Dangerous

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

May 15, 2023 Infusion Pumps Nationwide View Details →

ACROBAT SUV Vacuum Off-Pump System, Part Number C-OM-9000S. Component of a chest stabilization system for cardiac and chest surgery.

Maquet Cardiovascular

🏥 Medical Devices Class I - Dangerous

The Standard Blade may not securely latch onto the Activator Drive. This may result in the inability to stabilize and position or may result in the loss of stabilization and positioning of heart, release of device component into the patient, and/or a procedural delay and/or conversion.

Jun 28, 2023 Infusion Pumps Nationwide View Details →

ACCESSRAIL Platform (Standard Blade) Part Number SB-1000, and (Deep Blades) Part Number C-DB-1000. Component of a chest stabilization system for cardiac and chest surgery.

Maquet Cardiovascular

🏥 Medical Devices Class I - Dangerous

The Standard Blade may not securely latch onto the Activator Drive. This may result in the inability to stabilize and position or may result in the loss of stabilization and positioning of heart, release of device component into the patient, and/or a procedural delay and/or conversion.

Jun 28, 2023 Other Medical Devices Nationwide View Details →

ACROBAT-i Vacuum Stabilizer System, Part Number C-OM-10000. Component of a chest stabilization system for cardiac and chest surgery.

Maquet Cardiovascular

🏥 Medical Devices Class I - Dangerous

The Standard Blade may not securely latch onto the Activator Drive. This may result in the inability to stabilize and position or may result in the loss of stabilization and positioning of heart, release of device component into the patient, and/or a procedural delay and/or conversion.

Jun 28, 2023 Other Medical Devices Nationwide View Details →

OEC Flexiview 8800 Systems with 9-inch Image Intensifier

GE OEC Medical Systems

🏥 Medical Devices Class I - Dangerous

Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the systems encounter a large impact force when moved, which may result in the image intensifier falling, which could lead to injuries such as fractures, hematoma, contusion, bruise, pain.

May 15, 2023 Infusion Pumps Nationwide View Details →

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. OPEN HEART CDS-LF, Model Number: CDS840451L; b. OPEN HEART LINE SET UP, Model Number: DYNJ908179, DYNJ908179A; c. OPEN HEART PACK, Model Number: DYNJ43741B, DYNJ66216, DYNJ66216A, DYNJ66216B, DYNJ66216C; d. OPEN HEART PACK A B, Model Number: DYNJ53984G; e. OPEN HEART PACK A & B, Model Number: DYNJ0283397T, DYNJ0283397U, DYNJ53984F, DYNJ53984G; f. OPEN HEART PACK-LF, Model Number: DYNJ0371669N; g. OPEN HEART PACK-RF-LF, Model Number: DYNJ22232W; h. OPEN HEART PART 2, Model Number: DYNJ901075O, DYNJ901075P; i. OPEN HEART PROCEDURE, Model Number: DYNJ901821A; j. OPEN HEART TAVR CONVERSION PK, Model Number: DYNJ63153B; k. OPEN HEART TAVR PACK, Model Number: DYNJ63099F; l. OPEN VASCULAR UE, Model Number: DYNJ907858A; m. OPEN VASCULAR UE PACK, Model Number: DYNJ62451; n. OR ENDOVASCULAR, Model Number: DYNJ906019B, DYNJ906019C; o. OR INTERVENTIONAL PACK, Model Number: DYNJ81295; p. PACER SET UP PACK, Model Number: DYNJ63069A; q. PACK AV FISTULA, Model Number: DYNJ60115B; r. PACK MINOR VASCULAR, Model Number: NG340C; s. PACK VASCULAR BYPASS, Model Number: DYNJ905692D; t. PEDI EP PACK, Model Number: DYNJ54750G; u. PEDIATRIC CARDIO CATH PACK, Model Number: DYNJ35578G; v. PERCUTANEOUS VASCULAR CDS, Model Number: CDS840487I; w. PERIPHERAL CONTINUOUS NERVE BL, Model Number: PAIN1423A; x. PERIPHERAL VASCULAR, Model Number: DYNJ44562F, DYNJ901068D, DYNJ901068F, DYNJ901068I; y. PERIPHERAL VASCULAR GRAFT, Model Number: SYNJ910022A, SYNJ910022B, SYNJ910022C; z. PERIPHERAL VASCULAR PACK, Model Number: DYNJ82566; aa. PERMA CATH PACK, Model Number: DYNJ62007B; bb. PICC VASCULAR ACCESS PACK, Model Number: PICCNC0010; cc. PK OPEN HEART, Model Number: DYNJ45074C, DYNJ61645A; dd. PK, OPEN HEART, Model Number: DYNJ61645A; ee. PK, VASCULAR, Model Number: DYNJ54305; ff. PORT PACK, Model Number: DYNJ68990A; gg. PORT PICC TUNNEL PACK, Model Number: DYNJ65775A; hh. PQ2 VASCULAR PACK, Model Number: DYNJ68492; ii. PROCEDURE PACK, Model Number: DYNJ43922, DYNJ68968A, DYNJ81618; jj. PRX AV FISTULA PACK, Model Number: DYNJ66184; kk. PUH PERCUTANEOUS ECMO, Model Number: DYNJ907554A, DYNJ907554C; ll. PUMP PACK, Model Number: DYNJ64601B; mm. PURPLE PACK, Model Number: DYNJ62197A, DYNJ62197B; nn. PV CAROTID PACK, Model Number: DYNJ63341D; oo. PV PACK, Model Number: DYNJ46549K, DYNJ46549L; pp. RF OPEN HEART PACK (OHLUK)642, Model Number: DYNJ47660K; qq. RFA VEIN PACK-LF, Model Number: DYNJ61894A; rr. RFD-CAROTID, Model Number: DYNJ54287B; ss. RFD-ENDOVASCULAR OR PACK, Model Number: DYNJ54265A; tt. RFD-MAJOR VASCULAR, Model Number: DYNJ54285B; uu. RFD-MINOR VASCULAR, Model Number: DYNJ54286B; vv. RIGHT HEART PACK-LF, Model Number: DYNJ0565558U; ww. RIGHT HEART TRAY, Model Number: DYNJ40379D; xx. ROCKWAY VASCULAR PACK-LF, Model Number: DYNJ55757C; yy. RRMC CAROTID PACK-2, Model Number: DYNJ33544J, DYNJ33544K, DYNJ33544L; zz. SAC OPEN HEART DR. RUDERSDORF, Model Number: DYNJ908074B; aaa. SCA VEIN PACK, Model Number: DYNJ63817; bbb. SILVER CROSS OPEN HEART, Model Number: DYNJ906102D, DYNJ906102F; ccc. SMALL CARDIOVASCULAR PACK, Model Number: DYNJ83521; ddd. SMALL TRAY VASCULAR PACK, Model Number: DYNJ65418; eee. SPECIALS MINOR RADIOLOGY PACK, Model Number: DYNJ82314; fff. ST CHARLES PORT PACK, Model Number: DYNJ49833I; ggg. ST MARY'S STL OPEN HRT SUPPLY, Model Number: DYNJ20031C; hhh. STEWARD OR VASCULAR PACK G, Model Number: DYNJ80918; iii. STEWARD VASCULAR SAS, Model Number: DYNJ908563; jjj. STROKE KIT, Model Number: DYNJ80506; kkk. STROKE PACK, Model Number: DYNJ69009, DYNJ69009A; lll. SUMMIT SKIN AND VEIN PACK, Model Number: DYNJ54014B; mmm. SVMMC CAROTID PACK, Model Number: DYNJ43861F; nnn. SVMMC AV

MEDLINE INDUSTRIES, LP - Northfield

🏥 Medical Devices Class I - Dangerous

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

May 15, 2023 Infusion Pumps Nationwide View Details →

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ART LINE KIT ICH OR, Model Number: ART900; b. ART LINE SECUREMENT KIT W/LIDOCAINE, Model Number: DT22570; c. ARTERIAL BUNDLE NO CATHETER, Model Number: ART995; d. ARTERIAL LINE INSERTION KIT, Model Number: ART775B; e. ARTERIAL LINE KIT W/O CATHETER, Model Number: ART890A; f. ARTERIAL LINE START KIT, Model Number: ART1160; g. ARTERIAL LINE START KIT W/O CATH, Model Number: P42453; h. ARTERIAL LINE TRAY W/O CATHETER, Model Number: ART1180; i. RADIAL ARTERIAL LINE KIT, Model Number: ART1070A

MEDLINE INDUSTRIES, LP - Northfield

🏥 Medical Devices Class I - Dangerous

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

May 15, 2023 Surgical Instruments Nationwide View Details →

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CVC PACK, Model Number: DYNJ46967F; b. ENDOVENOUS ABLATION PACK, Model Number: DYNJ64059; c. ENDOVENOUS CORE PACK: DYNJ62557; d. TVS4000 ENDOVENOUS PACK, Model Number: TVS4000K

MEDLINE INDUSTRIES, LP - Northfield

🏥 Medical Devices Class I - Dangerous

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

May 15, 2023 Other Medical Devices Nationwide View Details →

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. 7F, 20CM TRIPLE LUMEN CVC BUNDLE, Model Number: ECVC4740; b. A V GRAFT, Model Number: DYNJ36212C; c. AAA, Model Number: DYNJ905651, DYNJ905651A, DYNJ905651B; d. AAA PACK, Model Number: DYNJ44918C; e. AAA PACK - TEAM 3, Model Number: DYNJ44847G; f. ABLATION PACK, Model Number: DYNJ62540, DYNJ64068; g. ABLATION/DRAINAGE PACK, Model Number: DYNJ53658A; h. ACCESS KIT, Model Number: DYNDH1159A; i. ACCESS PACK, Model Number: DYNJ69017; j. ACCESSORY KIT, Model Number: DYNJ901348D; k. ADULT CORONARY PACK, Model Number: DYNJV0275F; l. ADULT CVC MAX BARRIER KIT-LF, Model Number: DYNJ38714B; m. ALL PURPOSE TRAY FOAKS, Model Number: DYNJ63576, DYNJ63576A; n. AMINO KIT; Model Number: DYNDH1649; o. AMNIOCENTESIS TRAY, Model Number: DYNDH1420; p. ANGIO STANDARD PACK-LF, Model Number: DYNJ0370436Q; q. ANGIO TRAY, Model Number: DYNJ23438J; r. ANGIOGRAM PACK, Model Number: DYNJ47004B; s. ANGIOGRAM TRAY, Model Number: DYNJ33638I; t. ANGIO-VASCULAR, Model Number: DYNJ24272B; u. ARTERIAL PACK, Model Number: DYNJ51340D; v. ARTERIO-VENOUS CDS, Model Number: CDS984186C; w. ASPIRATION TRAY, Model Number: DYNDH1467; x. ASPIRE EXACT TRAY, Model Number: DYNJRA1716, DYNJRA1716A; y. BARIATRIC LAPAROSCOPY R-Y PACK, Model Number: DYNJC9299L; z. BASIC PACK, Model Number: DYNJ37460A, DYNJ42691, DYNJ52122B, DYNJ52171, DYNJ55456, DYNJ55457, DYNJ81343; aa. BASIC PROCEDURE PACK, Model Number: DYNJ53122B; bb. BASIC VEIN PACK, Model Number: DYNJ58650; cc. BEDSIDE PROCEDURE PREP KIT, Model Number: MNS7695A; dd. BGMC LIVER TRANSPLANT, Model Number: DYNJ9664651D; ee. BIOPSY TRAY, Model Number: DYNDH1340; ff. BLOCK KIT, Model Number: DYNJRA1145; gg. BLOCK SUPPLIES NDL CNTR, Model Number: DYNJRA1755; hh. BREAST ULTRASOUND PROCEDURE TR, Model Number: DYNDL1596A; ii. BUNDLE KIT, Model Number: DYNJ49737B, DYNJ49737C; jj. C V MAJOR PACK, Model Number: DYNJ64861; kk. CABG UNIVERSITY HOSP PACK-LF, Model Number: DYNJ0375705L; ll. CAROTID ENDARTERECTOMY, Model Number: DYNJ905640; mm. CHEST TUBE INSERTION TRAY, Model Number: TRICHT1120; nn. CHP TRANSPLANT CDS, Model Number: CDS983082I, CDS983082J; oo. CLINIC PACK, Model Number: DYNJRA1578; pp. CLOSURE CDS, Model Number: CDS983704G, CDS983704I; qq. CLOSURE FAST PACK UNIV, Model Number: DYNJ53482A; rr. CLOSURE PACK, Model Number: DYNJ54437A, DYNJ54437C, DYNJ57514, DYNJ60804; ss. CLOSURE PACK-LF, Model Number: DYNJ0807503M; tt. CLOSURE PROCEDURE, Model Number: DYNJ59206; uu. CLOSURE PROCEDURE PACK, Model Number: DYNJ66741; vv. CLOSURE PROCEDURE PKSJO-LF, Model Number: DYNJ35409F; ww. CLOT RETRIEVAL PACK, Model Number: DYNJ56140B; xx. CLOVIS MINOR IR PROCEDURE-LF, Model Number: DYNJ61067; yy. COMMANDO PACK MSH-LF, Model Number: DYNJ48525D; zz. CONTINUOUS BLOCK, Model Number: DYNJRA0960B; aaa. COPS PROCEDURE PACK-LF, Model Number: DYNJ68923A; bbb. CRMC MINOR IR PROCEDURE PK-LF, Model Number: DYNJ61099, DYNJ61099A; ccc. CV AAA PACK W AUX, Model Number: DYNJ65710; ddd. CV ACCESS PACK WRO-LF, Model Number: DYNJ41875B; eee. CV CDS, Model Number: CDS985395C; fff. CV MINOR CDS, Model Number: CDS984100T; ggg. CV PACK, Model Number: DYNJ45074B; hhh. CVC PACK, Model Number: DYNJ44010; iii. CVL PACK, Model Number: DYNJ00281N; jjj. CVOR CDS-LF, Model Number: CDS840198V; kkk. CYSTO PACK SMGH-LF, Model Number: DYNJ41915A; lll. DAVIES PHALLOPLASTY PACK, Model Number: DYNJ52185F; mmm. DAVINCI, Model Number: DYNJ906543A; nnn. DBD-BASIC PACK, Model Number: DYNJ55458; ooo. DBD-BIOPSY PACK-LF, Model Number: DYNJ0747885F; ppp. DBD-DONOR FREE FLAP PACK-LF, Model Number: DYNJ0426069M; qqq. DBD-ECMO MODULE PACK, Model Number: DYNJ55669F; rrr. DBD-EVLA PACK, Model Number: DYNJ6

MEDLINE INDUSTRIES, LP - Northfield

🏥 Medical Devices Class I - Dangerous

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

May 15, 2023 Infusion Pumps Nationwide View Details →

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIO, Model Number: DYNJ905151A; b. ANGIO/VENO PACK, Model Number: DYNJ58346A; c. ANGIOGRAPHIC PACK, Model Number: DYNJ57442C, DYNJ64081A; d. ANGIOGRAPHY PACK, Model Number: DYNJ65963; e. ANGIOPLASTY PACK-LF, Model Number: DYNJ64655; f. ARTHROGRAM TRAY, Model Number: SPEC0232; g. BASIC CATH/ANGIO, Model Number: DYNJ62591A; h. BASIC PACK, Model Number: DYNJ39752A; i. C.I.C.N. ANGIO PACK, Model Number: DYNJ53064B; j. CATH ANGIO PACK, Model Number: DYNJ64050; k. DBD-KIT NEURO CAROTID SETUP, Model Number: DYKMBNDL148; l. DBS PACK-LF, Model Number: DYNJ0878178I; m. GENERAL ANGIO PACK, Model Number: DYNJ57760A; n. GHIASSI NEURO ANGIO PACK-LF, Model Number: DYNJ57032C; o. IR NEURO PACK, Model Number: DYNJ39198L, DYNJ39198N; p. KIT OR AORTOGRM ANGIOPLAST PHT, Model Number: DYNJ906086A; q. MAIN BASIC NEURO, Model Number: DYNJ908260; r. NEURO ACCESSORY PACK, Model Number: DYNJ66790, DYNJ66790A, DYNJ66790B; s. NEURO CATH PACK, Model Number: DYNJ69129, DYNJ83090; t. NEURO IR PACK, Model Number: DYNJ35066I, DYNJ35066J, DYNJ60701A, DYNJ60701B, DYNJ60701C; u. NEURO PACK, Model Number: DYNJ43934A, DYNJ61798D, DYNJ66241, DYNJ66241A, DYNJ66241B, DYNJ66241C, DYNJ66241D, DYNJ68956A, DYNJ68956B; v. NEURO RADIOLOGY PACK, Model Number: DYNJ51107A, DYNJ59903A, DYNJ59903B; w. NEURO TRAY, Model Number: DYNJ67075, DYNJ67075A; x. PACK PERCUTANEOUS ANGIO CHRG, Model Number: DYNJ60112A; y. PEDI ANGIO PACK-LF, Model Number: PHS41743B; z. PEDIATRIC CATH ANGIO PACK, Model Number: DYNJ54755C; aa. RADIOLOGY NEURO DRAPE PAC, Model Number: DYNJ61449; bb. RO-DIEP PACK, Model Number: DYNJ82393A;

MEDLINE INDUSTRIES, LP - Northfield

🏥 Medical Devices Class I - Dangerous

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

May 15, 2023 Other Medical Devices Nationwide View Details →

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ABLATION PACK, Model Number: DYNJ40629B; b. AV FISTULA PACK, Model Number: DYNJ81410B; c. BARIATRIC KIT, Model Number: DYNJ901145G; d. BARIATRIC LAPAROSCOPY R-Y PACK, Model Number: DYNJC9299M, DYNJC9299O; e. BARIATRIC PACK, Model Number: DYNJ24459P; f. CENTRAL CATHETER INSERTION PK, Model Number: DYNJ36242; g. CYSTO PACK, Model Number: DYNJ60667C, DYNJ60667D, DYNJ60667F, DYNJ83942; h. DBD-FETOSCOPIC, Model Number: DYNJ905761A; i. DBD-FREE FLAP NO DRAPE PACK NTX, Model Number: DYNJ68447B; j. DBD-HILLCREST PCNL PACK, Model Number: DYNJ69204A; k. DIEP, Model Number: DYNJ901296B; l. DIEP FLAP, Model Number: DYNJ66867A; m. DONOR FREE FLAP PACK-LF, Model Number: DYNJ0426069N; n. ECMO PACK, Model Number: DYNJ82517; o. ENDOLUMINAL ACCESSORY PACK, Model Number: DYNJ44210B; p. ENDOVASCULAR, Model Number: DYNJ63343G; q. EVLT SURGICAL PACK, Model Number: DYNJ48520; r. FETAL SURGERY CDS-LF, Model Number: CDS840214Q; s. FLAP, Model Number: DYNJ907076A, DYNJ907076B, DYNJ907076C; t. FLAP HARVEST PACK, Model Number: DYNJ58575B; u. FLAP RECONSTRUCTION PACK-LF, Model Number: DYNJ0378388O; v. FREE FLAP, Model Number: DYNJ905634B; w. FREE FLAP ACCESSORIES, Model Number: DYNJ80290; x. FREE FLAP BASIC SET-UP PK, Model Number: DYNJ0991320K; y. FREE FLAP BASIN PACK, Model Number: DYNJ69914; z. FREE FLAP NO DRAPE PACK NTX, Model Number: DYNJ68447, DYNJ68447A; aa. FREE FLAP PACK CTX, Model Number: DYNJ68380, DYNJ68380A, DYNJ68380B; bb. FREE FLAP PACK-LF, Model Number: DYNJ0049595C, DYNJ20495K; cc. GENERAL ANGIO PACK, Model Number: DYNJ57760; dd. GU DAVINCI CDS, Model Number: CDS982779L, CDS982779M; ee. HILLCREST PCNL PACK, Model Number: DYNJ69204; ff. KIT FREE FLAP MOSES, Model Number: DYNJ905366A, DYNJ905366B; gg. KIT STC PLASTIC FREE FLAP, Model Number: DYKMBNDL54A; hh. LAP CHOLE PACK, Model Number: DYNJ41208D; ii. LAPAROSCOPIC COLORECTAL PACK, Model Number: DYNJ80172, DYNJ80172A, DYNJ80172B; jj. MAIN ESOPHAGECTOMY PACK, Model Number: DYNJ68172A; kk. MAXIMAL BARRIER BEDSIDE PACK, Model Number: DYNJ53059A; ll. MINOR, Model Number: DYNJ906915; mm. MINOR CV, Model Number: DYNJ69898A; nn. MINOR PROCEDURE TRAY, Model Number: DYNDA2418; oo. PACK FREE FLAP CHRG, Model Number: DYNJ60242A; pp. PCNL PACK, Model Number: DYNJ0569950Q; qq. PLANO DIEP PACK, Model Number: DYNJ81751; rr. PORT PACK, Model Number: DYNJ61747C; ss. PROCEDURE PACK DR BILIMORI, Model Number: DYNJ908046C; tt. PV MINOR PACK, Model Number: DYNJ63879D; uu. RF PACK, Model Number: DYNJ52505A; vv. ROBOTIC, Model Number: DYNJ904219G, DYNJ904343C; ww. ROBOTIC PACK-LF, Model Number: DYNJ904250F; xx. ROBOTIC-LF, Model Number: DYNJ904254F; yy. ROBOTICS GYN, Model Number: DYNJ905824D; zz. SINGLE SHOT BLOCK, Model Number: DYNJRA0961A; aaa. TAA AAA, Model Number: DYNJ63339C; bbb. TURP PACK SMGH-LF, Model Number: DYNJ41927B; ccc. ULTRASOUND PACK-LF, Model Number: PHS751646C, PHS751646D;

MEDLINE INDUSTRIES, LP - Northfield

🏥 Medical Devices Class I - Dangerous

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

May 15, 2023 Surgical Instruments Nationwide View Details →

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. VASCULAR PACK, Model Number: DYNJ22350K, DYNJ22350L, DYNJ22676J, DYNJ23445F, DYNJ31902L, DYNJ31902M, DYNJ39432I, DYNJ39432J, DYNJ39432K, DYNJ41625B, DYNJ46246A, DYNJ53438A, DYNJ53610C, DYNJ53995G, DYNJ56791A, DYNJ56791B, DYNJ57490A, DYNJ58608, DYNJ58681A, DYNJ58681B, DYNJ58710, DYNJ61325A, DYNJ61325B, DYNJ61528, DYNJ62399A, DYNJ65160, DYNJ66356, DYNJ66356A, DYNJ66356B, DYNJ66356C, DYNJ66356D, DYNJ66577, DYNJ68492A, DYNJ68492B, DYNJ68492C, DYNJ68492D, DYNJ68863, DYNJ68863A, DYNJ68880, DYNJ80599, DYNJ81626, DYNJ82016, DYNJ82104, DYNJ82144, DYNJ82769, DYNJ82769A, DYNJ83146; b. VASCULAR PACK CHRG, Model Number: DYNJ59778A, DYNJ59778B; c. VASCULAR PACK GWV, Model Number: DYNJ59245; DYNJ59245A; d. VASCULAR PACK MH-LF, Model Number: DYNJ39866B, DYNJ39866C; e. VASCULAR PACK SHD, Model Number: DYNJ68404; f. VASCULAR PACK-LF, Model Number: DYNJ0250564O, DYNJ0250564P, DYNJ0373040N, DYNJ0493141G, DYNJ0493141I, DYNJ0493141J, DYNJ0871182AC, DYNJ0901358I, DYNJ0901358J, DYNJ0901358K, DYNJ53475F, DYNJ53684A, PHS400047N, PHS400047O; g. VASCULAR STENT INOVA, Model Number: DYNJ906440A; h. VASCULAR TRAY, Model Number: DYNJ56858; i. VASCULAR/OR ANGIO, Model Number: DYNJ905079F; j. VASCULAR-LF, Model Number: DYNJ900714B, DYNJ900714C; k. VEIN ABLATION EXCISION ASC, Model Number: DYNJ52586B; l. VEIN ABLATION & EXCISION ASC, Model Number: DYNJ52586, DYNJ52586A, DYNJ52586B; m. VEIN ABLATION KIT, Model Number: DYNJ69272A; n. VEIN ABLATION PACK, Model Number: DYNJ62889; o. VEIN ABLATION TRAY W/CHLOR, Model Number: DYNJ64396; p. VEIN AND LASER PACK, Model Number: DYNJ49874; q. VEIN CENTER PACK, Model Number: DYNJ52123; r. VEIN CLINIC, Model Number: DYNJ68667; s. VEIN CLOSURE PACK, Model Number: DYNJ35586G, DYNJ39408F, DYNJ65189B; t. VEIN CLOSURE TRAY, Model Number: DYNJ44737B; u. VEIN KIT, Model Number: DYNJ57047; v. VEIN LIGATION, Model Number: DYNJ64190; w. VEIN OHH, Model Number: DYNJ65560A; x. VEIN PACK, Model Number: DYNJ21949J, DYNJ39005B, DYNJ39889, DYNJ48493, DYNJ48907F, DYNJ50785, DYNJ52098, DYNJ52993A, DYNJ53160, DYNJ53160A, DYNJ54153B, DYNJ55268, DYNJ55462A, DYNJ55514A, DYNJ55849A, DYNJ56624, DYNJ56724A, DYNJ56724B, DYNJ57512, DYNJ57835, DYNJ57917, DYNJ58063, DYNJ58609, DYNJ59151F, DYNJ59662B, DYNJ59662D, DYNJ59677A, DYNJ59681A, DYNJ61540C, DYNJ63823, DYNJ64282, DYNJ64471A, DYNJ65579, DYNJ66154, DYNJ66743A, DYNJ68749, DYNJ69091, DYNJ80199A, DYNJ80199B, DYNJ80868, DYNJ83147; y. VEIN PACK II, Model Number: DYNJ66427; z. VEIN PACK-LF, Model Number: DYNJ66271A, DYNJ66271C; aa. VEIN PROCEDURE, Model Number: DYNJ65342A; bb. VEIN PROCEDURE PACK, Model Number: DYNJ38264D, DYNJ62038A, DYNJ64909; cc. VEIN SPECIALISTS PACK, Model Number: DYNJ53616A; dd. VEIN TRAY, Model Number: DYNJ57003, DYNJ62829A; ee. VENOUS ABLATION, Model Number: DYNJ50227C; ff. VENOUS ACCESS ACCESSORY PACK, Model Number: DYNJ61010A; gg. VENOUS ACCESS PACK, Model Number: DYNJ44421D; hh. VIRC STROKE PACK, Model Number: DYNJ83461; ii. VNUS, Model Number: CDS984292I; jj. VNUS CLOSURE, Model Number: DYNJ66076; kk. VNUS VASCULAR PACK, Model Number: DYNJ66445; ll. WA VASCULAR PACK-LF, Model Number: DYNJ33612G

MEDLINE INDUSTRIES, LP - Northfield

🏥 Medical Devices Class I - Dangerous

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

May 15, 2023 Implants & Prosthetics Nationwide View Details →

Medline Probe Cover Kits containing Turkuaz Ultrasound Gel, Labeled as the following: a. COVER, PROBE, W/GEL AND BANDS, 4X48 - Model Number DYNJE5900; b. COVER, PROBE, W/GEL AND BANDS, 6X24 - Model Number DYNJE5910; c. COVER, PROBE, W/GEL AND BANDS, 6X48 - Model Number DYNJE5920; d. COVER, PROBE, W/GEL AND BANDS, 6X96 - Model Number DYNJE5930; e. COVER, PROBE, W/GEL AND BANDS, 5X48 - Model Number DYNJE5940; f. COVER, PROBE, W/GEL AND BANDS, 4X48 - Model Number DYNJEX5900

MEDLINE INDUSTRIES, LP - Northfield

🏥 Medical Devices Class I - Dangerous

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

May 15, 2023 Other Medical Devices Nationwide View Details →