Medical Device Recalls

Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. Total cervical disc replacement.

Centinel Spine, Inc.

SMART FLEX 10x100 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of maligna

Cordis Corporation

Palindrome RT Repair Kit 15 FR TAL 44cm, Sterile, Item Code 8888541144

Covidien, LP

HUDSON RCI mBrace, ET Tube Holder with Bite Block and 4 Point Head Strap, REF DYNJMBRC4B; tracheal tube fixation device

MEDLINE INDUSTRIES, LP - Northfield

ICU Medical 30" (76 cm) Appx 3.3 mL, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Hanger, Drop-In Re

ICU Medical, Inc.

VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use

Ethicon, Inc.

Atomlab 500 Dose Calibrator Software 2.0.00 through Revision 2.0.08, inclusive Model: 086-330.

Biodex Medical Systems, Inc.

VOLISTA StandOP Surgical Light, Product Code/Part Numbers ARD568811901 VLT600SF AIM STP ARD568811911 VLT600SF AIM STP

Getinge Usa Sales Inc

DJO Surgical: CLP Hip, Stem, Polished Neck, Lateral Offset Implant, Size#3, REF: 426-11-030

Encore Medical, LP

Medline Sterile 0.9% Normal Saline, USP, 100mL, REF RDI30296

MEDLINE INDUSTRIES, LP - Northfield

BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, used with Maine Molecular Quality Controls, In

BioFire Diagnostics, LLC

MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01

Datascope Corp.

CooperSurgical H/S CATHETER SET FR 5 with Integated Stylet Model: 61-4005S For administering contrast media during Hys

CooperSurgical, Inc.

GETINGE USA SALES LLC OCEAN Chest Drain System Atrium 2100 mL Model Number: 2002-000

Mckesson Medical-Surgical Inc. Corporate Office

BD PYXIS MEDBANK TWR MN CR-6HH-1FH-3FM-P, REF: 169-92 containing software version 3.9.1.9

CareFusion 303, Inc.

PriMatrix Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 4x4 cm, 6x6 cm, 8x8 cm, 14mm Disc, 18mm Disc, 2x2 cm, and

TEI Biosciences, Inc.

Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWS-35-80 ORDER NUMBER (GPN): G56151. F

Cook Incorporated

Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ENDO BRONCH PACK, Pack Number DYKE

MEDLINE INDUSTRIES, LP - Northfield

Baxter Stationary column TruSystem 7500, Product Code 1717020

Baxter Healthcare Corporation

Hobbs Posi-Stop Injection Needle Catalog Number: 4718

Hobbs Medical, Inc.

Impella 5.0 intravascular micro axial blood pump, Product Number 005062

Abiomed, Inc.

ICD-DR DDBB1D4 EVERA XT IS1/DF4 US, Model Number DDBB1D4; Implantable Cardioverter Defibrillators

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Ref No: INS7260 / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the bra

Integra LifeSciences Corp.

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001876;

Beaver Visitec International, Inc.

Senior Living Arial Emergency and Nurse Call Systems

Stanley Security Solutions Inc

GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system

GE Healthcare GmbH

VIDAS CLINICAL VIDAS SALMONELLA 60T, CATALOG 30702

Biomerieux Inc

PPM LOMBARD PRODUCTS TSA 3P W NEUTRALIZERS 100 PLT, CATALOG 423723

Biomerieux Inc

Cardiosave Rescue. Model Number: 0998-00-0800-83.

Datascope Corp.

Medtronic DLP Vessel Cannula, Model Number REF 30000

Medtronic Perfusion Systems