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Other Medical Devices

🏥 Medical Devices • 15,203 recalls

BD Pyxis MedStation ES AUX, REF 324

CareFusion 303

Class I - Dangerous

Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur have been identified: Situation 1: Door Latch Failure, Situation 2: Cable Ribbon Damage, Situation 3: Magnet Falling Out,

Feb 14, 2023 Other Medical Devices View Details →

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE HEGAR DILATOR 11&12MM STRLCS25Model Number 96-0960; 2) ECONO STERILE HEGAR DILATOR 9&10MM STRL CS25Model Number 96-0961; 3) ECONO STERILE HEGAR DILATOR 7&8MM STRL CS25Model Number 96-0962; 4) ECONO STERILE HEGAR DILATOR 5&6MM STERL CS25Model Number 96-0963; 5) ECONO STERILE HEGAR DILATOR 3&4MM STERL CS25Model Number 96-0964; 6) ECONO STERILE HEGAR DILATOR 1&2MM STERL CS25Model Number 96-0965; 7) ECONO STERILE HANK DILATOR 5.5&6MM STRL CS25Model Number 96-0966; gynecological dilators

Sklar Instruments

Class I - Dangerous

Reports of various packaging issues that may result in a breach of the sterile barrier.

Dec 3, 2024 Other Medical Devices Nationwide View Details →

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ROCH-PEAN FCP 8" CVD CS/25,Model Number 94-0286; 2) ECONO STERILE DRESSING FCP 5.5" CS/25LG,Model Number 94-0290; 3) ECONO STERILE TISSUE FCP 1X2 5.5" STER CS25,Model Number 94-0291; 4) ECONO STERILE FRCPS JANSEN BAYO STRL6.25 C25,Model Number 941-0691; 5) ECONO STERILE IRIS FCP SERR 4.25 STER CS100,Model Number 941-1414; 6) ECONO STERILE PEDIATRIC MAGILL CATH FCP CS25,Model Number 94-1924; 7) ECONO STERILE STRL ALLIGATOR FCPS 3.5" 25/CS,Model Number 94-5034; 8) ECONO STERILE SERR DRESSING FCP 5 1/2" CS/50,Model Number 94-6146; 9) ECONO STERILE KELLY RANKIN FCP CVD 6.25 CS25,Model Number 94-6616; 10) ECONO STERILE JANSEN NSL FCP BY6.5 STRLCS/25,Model Number 96-2215A; 11) ECONO STERILE BALLENGR SPNG FCP SERR7"CS/25,Model Number 96-2289; 12) ECONO STERILE LUCAE BAYONET FCP SERR5.5CS/25,Model Number 96-2293; 13) ECONO STERILE LUCAE BAYONET FCP SERR5.5CS/25,Model Number 96-2293A; 14) ECONO STERILE RUSSIAN TISSUE FCP 6" STER25,Model Number 96-2295A; 15) ECONO STERILE TISSUE FCP 1X2 8" STRL CS/25,Model Number 96-2351; 16) ECONO STERILE SCHROEDER BRAUN TEN FCP10CS/25,Model Number 96-2386; 17) ECONO STERILE TUBE OCCL FCP SM STR 7"STER 50,Model Number 96-2406; 18) ECONO STERILE TUBE OCC FCP SM STR 7" STER 25,Model Number 96-2408; 19) ECONO STERILE FN-PT SPLINT FCP 4 1/2 STER 50,Model Number 96-2410; 20) ECONO STERILE FN-PT SPLINT FCP 4 1/2 STER 25,Model Number 96-2412; 21) ECONO STERILE FN-PT SPLINT FCP 4 1/2 STER 25,Model Number 96-2412A; 22) ECONO STERILE FN-PT SPLINT FCP 4 1/2 STER 25,Model Number 96-2412M; 23) ECONO STERILE SEMKEN DRESS FCP SERR 5"STER25,Model Number 96-2450M; 24) ECONO STERILE RANKIN KELLY FCP STR6.25 CS/25,Model Number 96-2461; 25) ECONO STERILE RANKIN KELLY FCP CVD6.25 CS/25,Model Number 96-2462; 26) ECONO STERILE IRIS FCP X-FINE ANG 3.5 STER25,Model Number 96-2470A; 27) ECONO STERILE IRIS FCP X-FINE STR 3.5 STER25,Model Number 96-2472A; 28) ECONO STERILE IRIS FCP 1/2CVD SERR STER CS25,Model Number 96-2515; 29) ECONO STERILE IRIS FCP 1/2CVD 1x2 STER CS25,Model Number 96-2515A; 30) ECONO STERILE FOERSTER SPONGE FCP 9.5 STER50,Model Number 96-2532; 31) ECONO STERILE FOERSTER SPONGE FCP 9.5 STER25,Model Number 96-2533; 32) ECONO STERILE FOERSTER SPONGE FCP 9.5 STER25,Model Number 96-2533A; 33) ECONO STERILE SPONGE FCP STR SERR 9.5 STER25,Model Number 96-2533M; 34) ECONO STERILE FOERSTER SPG FCP CVD 9.5STER25,Model Number 96-2534; 35) ECONO STERILE FOERSTER SPG FCP CVD 9.5STER25,Model Number 96-2534A; 36) ECONO STERILE IRIS FCP STR 1X2 4" STER CS/25,Model Number 96-2535A; 37) ECONO STERILE HALSTED FCP STR 5" STER CS/50,Model Number 96-2536; 38) ECONO STERILE HALSTED FCP STR 5" STER CS/50,Model Number 96-2536M; 39) ECONO STERILE HALSTED FCP STR 5" STER CS/25,Model Number 96-2537; 40) ECONO STERILE HALSTED FCP STR 5" STER CS/25,Model Number 96-2537A; 41) ECONO STERILE HALSTED FCP STR 5" STER CS/25,Model Number 96-2537M; 42) ECONO STERILE HALSTED FCP CVD 5" STER CS/50,Model Number 96-2538; 43) ECONO STERILE HALSTED FCP CVD 5" STER CS/25,Model Number 96-2539; 44) ECONO STERILE HALSTED FCP CVD 5" STER CS/25,Model Number 96-2539A; 45) ECONO STERILE HALSTED FCP CVD 5" STER CS/25,Model Number 96-2539M; 46) ECONO STERILE ROCH PEAN FCP STR STER 61/4 50,Model Number 96-2544; 47) ECONO STERILE ROCH PEAN FCP STR STER 61/4 25,Model Number 96-2545; 48) ECONO STERILE ROCH PEAN CVD 6 1/4 STERL CS25,Model Number 96-2547; 49) ECONO STERILE ROCH PEAN CVD 6 1/4 STER CS/25,Model Number 96-2547A; 50) ECONO STERILE ROCH-PEAN FCP CVD 8.5" STER 25,Model Number 96-2548; 51) ECONO STERILE ROCH-PEAN FCP CVD 8.5" STER 50,Model Number 96-2549; 52) ECONO STERILE CRILE FCP STR 5.5" STERL CS/50,Model Number 96-2550; 53) ECONO STERILE CRILE FCP STR 5.5" STERL CS/25,Model Number 96-2551; 54) ECONO STERILE CRILE FCP STR 5.5" STERL CS/25,Model Number 96-2551A;

Sklar Instruments

Class I - Dangerous

Reports of various packaging issues that may result in a breach of the sterile barrier.

Dec 3, 2024 Other Medical Devices Nationwide View Details →

Impella RP Flex with SmartAssist; Product Number: 1000323;

Abiomed

Class I - Dangerous

Optical Sensors have been damaged due to physical interaction between the inlet and another device resulting in a Placement Signal Not Reliable (PSNR) alarm and loss of Central Venous (CV) Placement Signal, Pulmonary Artery (PA) Placement Signal & Pulmonary Artery Pulse Index (PAPi) metrics. Abiomed is reinforcing that there is a risk of potential interaction between the tip of guidewires, indwelling central venous lines or devices and inlet of the Impella pumps listed above during the insertion, manipulation, and removal of those devices. The interaction may result in optical sensor damage, temporary pump stop, or permanent pump stop.

Dec 12, 2024 Other Medical Devices Nationwide View Details →

nuwellis AquaFlexFlow UF 500 Plus, REF 114156, Catalog Number A06163, extracorporeal blood circuit which is used with the Aquadex SmartFlow or Aquadex FlexFlow System

Nuwellis

Class I - Dangerous

The AquaFlexFlow UF 500 Plus extracorporeal blood circuit used with the Aquadex SmartFlow and FlexFlow Systems may indicate "Ultrafiltrate Weight Mismatch" or Excessive Weight Mismatch Alarms while in use. If not addressed, this failure could result in excess fluid removal from a patient leading to Acute Volume Depletion. This failure is especially serious when the Aquadex System is being used on pediatric patients.

Dec 11, 2024 Other Medical Devices Nationwide View Details →
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