Medical Device Recalls

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

B Braun Medical Inc

Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780035

TELEFLEX LLC

Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 7821

Philips North America

MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography system.

Mobius Imaging, LLC

Medfusion Syringe Pump, Model 3500VX-500, v3, v4, v5, and v6

Smiths Medical ASD Inc.

Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat

B Braun Medical Inc

Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model No

ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY

Atrium Pneumostat Chest Drain Valve, Part Number 16100

Atrium Medical Corporation

medex TranStar KIDS KIT 7INCH CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9547

Smiths Medical ASD, Inc.

iCast Covered Stent System Product Code/Part Number: 85400 85401 85402 85403 85404 85405 85406 85407 85408

Atrium Medical Corporation

RADPRO MOBILE, Mobile X-ray system

SEDECAL SA

SERIES II TIBIAL BEAR INSERT-Intended for knee replacement Part Number: 3052-0524

Howmedica Osteonics Corp.

SIMPLY SALINE NASAL MIST 3.1 OZ, SKU 999801

Family Dollar Stores, Llc.

BD Pyxis MedStation ES AUX Tower REF 343 BD Pyxis " MedStation 4000 AUX Tower REF 314 The BD Pyxis" MedStation ES

CareFusion 303, Inc.

MEDLINE Medical Procedure Kits labeled as: NURSING KIT, Medline Kit Number/SKU EDUC1044

Medline Industries, LP

Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a multiplex real-time reverse transcription (

Abbott Molecular, Inc.

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001527;

Beaver Visitec International, Inc.

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

B Braun Medical Inc

SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7521

Howmedica Osteonics Corp.

SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial Heart System (50CC): 570500-000

SynCardia Systems LLC

MEDLINE Kits, trays, and packs labeled as follows: a) C-SECTION, REF DYNJ904653G; b) DRESSING TRAY, REF M101426;

MEDLINE INDUSTRIES, LP - Northfield

CRTD DTMB1Q1 AMPLIA MRI QUAD US DF1, Model Number DTMB1Q1; Implantable Cardioverter Defibrillators

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

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001637;

Beaver Visitec International, Inc.

Power electronic box, Part #AS-0066, subassembly for the MyoCycle MC-2.

Myolyn Inc.

Medline Convenience kits labeled as: 1) CHEST TUBE TRAY , Pack Number CHT2120; 2) CHEST TUBE INSERTION TRAY , Pack

MEDLINE INDUSTRIES, LP - Northfield

AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553670

Boston Scientific Corporation

Kit Label: Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-2 Anti-FITC-AP CISH Accessory Kit (Dako Omn

Agilent Technologies, Inc.

Baxter EXACTAMIX Inlet, Vented, High Volume Inlet, REF H938174, for use in a pharmaceutical compounding device

Baxter Healthcare Corporation

Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF BXAL085902E, 8 MM X 59 MM 8 Fr, LARGE BALLOON EXPANDLB

W L Gore & Associates, Inc.

COOK MEDICAL Multipurpose Drainage Catheter: Reference Part Number ULT8.5-38-25-P-CLMS-8-RH-FS, Order Number G29775

Cook Incorporated