Medical Device Recalls

BD Syringe Set 20 DP MIC TBG 0.2MF CKV Anti-Siphon SmartSite VLV Sensing Disc, REF: 10798696; BD Syringe Set 20 DP MIC T

CAREFUSION

medex TranStar 60in (152cm) Single Monitoring Kit 10/EA, Product Code REF MX9504T

Smiths Medical ASD, Inc.

Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus REFURBISHED, REF IAP-0700X (IPN914274), cardiac pump

ARROW INTERNATIONAL Inc.

Medline Convenience kits labeled as: 1) OFFICE PACK FOR HYSTEROSCOPY, Pack Number C040100; 2) LAVH CDS, Pack Number C

MEDLINE INDUSTRIES, LP - Northfield

Medline Convenience kits labeled as: 1) OSTEOTOMY ORAL PROCEDURE, Pack Number CDS983010J ; 2) ORAL SURGERY PACK , P

MEDLINE INDUSTRIES, LP - Northfield

Bard¿ PreVent¿ Anti-Reflux Filter with ENFit, REF EN0046000

C.R. Bard Inc

NaviNetics Skull Anchor Key and Drill Kit, REF NN1215

Navinetics Inc

Giraffe OmniBed Field Replaceable Unit (FRU), Model Numbers 6600-1056-400 and 6600-1461-500

GE Medical Systems, LLC

Brand Name: Broselow Product Name: Broselow Domestic Complete ALS Organizer Model/Catalog Number: 7730ALS Software Ve

SunMed Holdings, LLC

FloPatch FP120, REF: FP120-FOT01-005

Flosonics Medical (R/A 1929803 ONTARIO CORP.)

Centurion procedure packs, containing Caina syringes, labeled as: SHAVE KIT, Pack Number MNS8250

MEDLINE INDUSTRIES, LP - Northfield

Evolution Upgrade 1.5T Model Numbers (REF): (1) 782116, (2) 782148;

Philips North America

Smith and Nephew EVOS Self-Tapping Locking Screw SST: (1)REF 72413575, 3.5MM x 75MM, and (2) REF 72413570, 3.5MM X 70MM

Smith & Nephew, Inc.

Infusomat UNIV.15DROP PUMP SET W/3 SAFELINE LL-Used with an electrically-powered infusion pump for intravenous (IV) adm

B. Braun Medical, Inc.

BD Pyxis Anesthesia Station ES REF: 327 Medication cabinet

CareFusion 303, Inc.

Sedecal Easy Moving Plus Model Number SM-50HF-B-D-C; 50KW 50G, Mobile X-ray system

SEDECAL SA

The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI scintillator FDR D-EVO2 (DR-ID) 12XXSE)

FUJIFILM Healthcare Americas Corporation

V6-2 Transducer Probe

Philips Ultrasound, Inc

Olympus High Flow Insufflation Unit. Model Number: UHI. Used for insufflation of the abdominal cavity, and automatic

Olympus Corporation of the Americas

ICU Medical 73" (185 cm) Appx 2.5 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, ChemoLock w/Red Cap REF: CL4176

ICU Medical, Inc.

Medtronic SynchroMed, Model A10

Medtronic Inc.

Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10

Cepheid

Malosa Core Phaco Pack 2- Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery.

Beaver Visitec International, Inc.

Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T,

Bard Peripheral Vascular Inc

IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102

Volcano Corp

Centurion STERILE BLOOD COLLECTION TUBE,10ML, Product Code 6430ST

MEDLINE INDUSTRIES, LP - Northfield

Baxter NovumIQ Syringe INFUSION SYSTEM , REF 40800BAXUS

Baxter Healthcare Corporation

Dual Articulating Headrest, Pad Ret P/N P141210805, REF BF754

Steris Corporation

CRTD DTMA2QQ CLARIA MRI QUAD OUS DF4, Model Number DTMA2QQ; Implantable Cardioverter Defibrillators

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

VITEK 2 REAGENT AST-GP67 TEST KIT 20 CARDS, CATALOG 22226

Biomerieux Inc