EXP Pharmaceutical Services Recalls

Medical Device Exchange PT WIRE 300; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 38931-04; EXP (repackager), Boston Scientific (OEM) Wire, guide, catheter

Class I - Dangerous

EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.

Feb 11, 2015 Surgical Instruments View Details →

Medical Device Exchange 2.15MMX22MM Fluted Spiral Router for CRANI-A; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number A-CRN-S; EXP (repackager), Anspach (OEM) Bur, surgical, general & plastic surgery

Class I - Dangerous

EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.

Feb 11, 2015 Surgical Instruments View Details →

Medical Device Exchange -Suction Coagulator; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number E2505-10FR; EXP (repackager), Valleylab (OEM) Electrosurgical, cutting & coagulation & accessories

Class I - Dangerous

EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.

Feb 11, 2015 Surgical Instruments View Details →

Medical Device Exchange ETS FLEX 45 ENDOSCOPIC ARTICULATING LINEAR CUTTER, 45MM STAPLE; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number ATS45; EXP (repackager), Ethicon (OEM) Implantable Staple.

Class I - Dangerous

EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.

Feb 11, 2015 Implants & Prosthetics View Details →

Medical Device Exchange SECURESTRAP 5mm Absorbable Strap Fixation Device; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number STRAP25; EXP (repackager), Ethicon (OEM) Strap, implantable.

Class I - Dangerous

EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.

Feb 11, 2015 Implants & Prosthetics View Details →

Medical Device Exchange Wire (sternotomy wire); Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 046-072; 046-073; EXP (repackager), A & E Medical (OEM) Suture, nonabsorbable

Class I - Dangerous

EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.

Feb 11, 2015 Other Medical Devices View Details →

Medical Device Exchange Round Diamond Bur Extra Coarse; 3.0mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 5820-10-130; EXP (repackager), Stryker (OEM) Drills, burrs, trephines & accessories (simple, powered)

Class I - Dangerous

EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.

Feb 11, 2015 Other Medical Devices View Details →

Medical Device Exchange Insufflation Needle; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number C2201; EXP (repackager), Medline (OEM) Insufflator, laparoscopic

Class I - Dangerous

EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.

Feb 11, 2015 Surgical Instruments View Details →

Medical Device Exchange - Endo Catch 10mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 173050G; EXP (repackager), Auto Suture (OEM) Endoscope and Accessories

Class I - Dangerous

EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.

Feb 11, 2015 Other Medical Devices View Details →

Medical Device Exchange - Mayfield Disposable Skull Pin; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number A1072; EXP (repackager), Integra (OEM) Holder, head, neurosurgical (skull clamp)

Class I - Dangerous

EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.

Feb 11, 2015 Surgical Instruments View Details →

Medical Device Exchange 3.5mm Threaded Cerclage Pin; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 298.838S; EXP (repackager), Synthes (OEM) Cerclage, fixation

Class I - Dangerous

EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.

Feb 11, 2015 Other Medical Devices View Details →

Medical Device Exchange 10x40 Airway Stent System; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 90129-209; EXP (repackager), Aero (OEM) Prosthesis, tracheal, expandable

Class I - Dangerous

EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.

Feb 11, 2015 Implants & Prosthetics View Details →

Medical Device Exchange TAUT Intraducer Peritoneal Catheter 2mm x 1.6mm x 7.6cm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number PI-63; EXP (repackager), Teleflex (OEM) Catheter, biliary, surgical

Class I - Dangerous

EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.

Feb 11, 2015 Surgical Instruments View Details →

Medical Device Exchange 10MM VASCULAR; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 9-AVP2-010; EXP (repackager), Aga Medical (OEM) Transcatheter septal occluder

Class I - Dangerous

EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.

Feb 11, 2015 Surgical Instruments View Details →

Medical Device Exchange Chocolate Balloon Catheter/Over-the-Wire; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number CF14-150-25040-OTW. EXP (repackager), TriReme Medical (OEM) Catheter, angioplasty, peripheral, transluminal

Class I - Dangerous

EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.

Feb 11, 2015 Surgical Instruments View Details →

Medical Device Exchange - Auto Suture Endo Universal 65¿¿ 4mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 173054; EXP (repackager), Tyco (OEM) Laparoscope, General & Plastic Surgery

Class I - Dangerous

EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.

Feb 11, 2015 Infusion Pumps View Details →

Medical Device Exchange Round Fluted Bur Soft Touch; 2.0mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 5820-10-120; EXP (repackager), Stryker (OEM) Drills, burrs, trephines & accessories (simple, powered)

Class I - Dangerous

EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.

Feb 11, 2015 Other Medical Devices View Details →

Medical Device Exchange Angio-Seal VIP Platform/Vascular Closure Device 6F; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 610130. EXP (repackager), St. Jude Medical (OEM) Device, hemostasis, vascular

Class I - Dangerous

EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.

Feb 11, 2015 Other Medical Devices View Details →

Medical Device Exchange - Dilating Tip Trocar w/Stability Sleeve 12mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number D12LT; EXP (repackager), Ethicon (OEM) Laparoscope, General & Plastic Surgery

Class I - Dangerous

EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.

Feb 11, 2015 Other Medical Devices View Details →

Medical Device Exchange Round Fluted Bur Aggressive; 4.0mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 5820-10-240; EXP (repackager), Stryker (OEM) Drills, burrs, trephines & accessories (simple, powered)

Class I - Dangerous

EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.

Feb 11, 2015 Infusion Pumps View Details →

Medical Device Exchange -SYSTEM, TACKER SKIN 5MM; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 6206; EXP (repackager), Covidien (OEM) Implantable Staple

Class I - Dangerous

EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.

Feb 11, 2015 Implants & Prosthetics View Details →

Medical Device Exchange FIBERWIRE SUTURE SCISSOR; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number AR-11796; EXP (repackager), Arrow (OEM) Electrosurgical, cutting & coagulation & accessories.

Class I - Dangerous

EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.

Feb 11, 2015 Surgical Instruments View Details →

Medical Device Exchange - 5.5mm BioComposite Corkscrew FT, Vented Suture Anchor; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number AR-1927BCF; EXP (repackager), Arthrex (OEM) Fastener, fixation, nondegradable, soft tissue

Class I - Dangerous

EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.

Feb 11, 2015 Other Medical Devices View Details →

Medical Device Exchange 12MM VASCULAR; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 9-AVP2-012; EXP (repackager), Aga Medical (OEM) Transcatheter septal occluder

Class I - Dangerous

EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.

Feb 11, 2015 Surgical Instruments View Details →

Medical Device Exchange - Trocar VersaPort Plus V2; 5mm -11mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 179095P; EXP (repackager), Auto Suture (OEM) Laparoscope, General and Plastic Surgery

Class I - Dangerous

EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.

Feb 11, 2015 Other Medical Devices View Details →

Medical Device Exchange 12x40 Airway Stent System; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 90129-212; EXP (repackager), Aero (OEM) Prosthesis, tracheal, expandable

Class I - Dangerous

EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.

Feb 11, 2015 Implants & Prosthetics View Details →

Medical Device Exchange PhysioMesh Flexible Composite Mesh 15 x 15cm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number PHY1515Q; EXP (repackager), Ethicon (OEM) Mesh, surgical, polymeric

Class I - Dangerous

EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.

Feb 11, 2015 Surgical Instruments View Details →

Medical Device Exchange 6.0mm Round Fluted Bur Soft Touch; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 5820-10-160; EXP (repackager), Stryker (OEM) Drills, burrs, trephines & accessories (simple, powered)

Class I - Dangerous

EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.

Feb 11, 2015 Other Medical Devices View Details →

Medical Device Exchange - GelPort Laparoscopic System; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number C8XX2N0NCE. EXP (repackager), Applied Medical (OEM) Laparoscope, General & Plastic Surgery.

Class I - Dangerous

EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.

Feb 11, 2015 Other Medical Devices View Details →

Medical Device Exchange - Loading Unit w/ DST Series Technology 60mm - 3.5mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number TA6035L; EXP (repackager), Covidien (OEM) Implantable Staple

Class I - Dangerous

EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.

Feb 11, 2015 Implants & Prosthetics View Details →

Medical Device Exchange - KII FIOS FIRST ENTRY 5X100MM; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number CFF03 EXP (repackager), Applied Medical (OEM) Laparoscope, General & Plastic Surgery.

Class I - Dangerous

EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.

Feb 11, 2015 Other Medical Devices View Details →

Medical Device Exchange - Versaport Bladeless Trocar w/ Fixation Cannula 5mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number NB5STF; EXP (repackager), Covidien (OEM) Laparoscope, General & Plastic Surgery

Class I - Dangerous

EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.

Feb 11, 2015 Other Medical Devices View Details →

Medical Device Exchange - Silicone Round Drain; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number SU130-1321; EXP (repackager), Jackson Pratt (OEM) Apparatus, suction, single patient use, portable, nonpowered

Class I - Dangerous

EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.

Feb 11, 2015 Other Medical Devices View Details →

Medical Device Exchange Aerosizer Stent Sizing Device; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 90129-501. EXP (repackager), Merit Medical (OEM) Prosthesis, tracheal, expandable

Class I - Dangerous

EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.

Feb 11, 2015 Implants & Prosthetics View Details →

Medical Device Exchange Surgical Gown - Flyte Hood Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 408-800 EXP (repackager) Stryker (OEM) Person protection during surgery.

Class I - Dangerous

EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.

Feb 11, 2015 Surgical Instruments View Details →

Medical Device Exchange - Dilating Tip Trocar w/Stability Sleeve 11mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number D11LT; EXP (repackager), Ethicon (OEM) Laparoscope, General & Plastic Surgery

Class I - Dangerous

EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.

Feb 11, 2015 Other Medical Devices View Details →

Medical Device Exchange -APPLIER, MULTICLIP ROTATING; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 3299; EXP (repackager), Covidien (OEM) Clip, implantable

Class I - Dangerous

EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.

Feb 11, 2015 Implants & Prosthetics View Details →

Medical Device Exchange BAG, SPECIMEN RETRIEVER ENDO; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 2444; EXP (repackager), Covidien (OEM) Specimen retriever bag.

Class I - Dangerous

EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.

Feb 11, 2015 Other Medical Devices View Details →

Medical Device Exchange - GIA Auto Suture Loading Unit w/ DST Series Technology 80mm - 4.8mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number GIA8048L; EXP (repackager), Covidien (OEM) Implantable Staple

Class I - Dangerous

EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.

Feb 11, 2015 Implants & Prosthetics View Details →

Medical Device Exchange FEMORAL CANAL TIP; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 210-8-N; EXP (repackager), Stryker (OEM) Lavage, jet

Class I - Dangerous

EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.

Feb 11, 2015 Other Medical Devices View Details →

Medical Device Exchange PhysioMesh Flexible Composite Mesh 10cm x 15cm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number PHY1015V; EXP (repackager), Ethicon (OEM) Mesh, surgical, polymeric

Class I - Dangerous

EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.

Feb 11, 2015 Surgical Instruments View Details →

Medical Device Exchange X-SAW BLADE; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 5059-531; EXP (repackager), Linvatic Corp (OEM) Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment

Class I - Dangerous

EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.

Feb 11, 2015 Surgical Instruments View Details →