Medical Device Recalls

Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit

ROi CPS LLC

Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: C-SECTION PREP, REF DYNJ32702B

MEDLINE INDUSTRIES, LP - Northfield

9 Coated Super and 9 Nude Super Tampons; Model Number: FG-TMP-REF00090009;

DAYE (ANNE'S DAY LTD)

STREAMLINE BLOODLINE SET FOR DIALOG-Tubing to be used to transfer blood between a patient and a haemodialyser during hae

B Braun Medical Inc

VITEK 2 REAGENT AST-GN79 TEST KIT 20 CARDS, CATALOG 413436

Biomerieux Inc

Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wi

Draegar Medical Systems, Inc.

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) LACERATION TRAY, Model Numbe

MEDLINE INDUSTRIES, LP - Northfield

Stimuplex A, 30 DEG, 24GX1", 0.55x25mm, Catalogue Number: 4894251.

B Braun Medical Inc

TactiFlex Ablation Sensor Enabled Ablation Catheter, Models A-TFSE-FJ, 7.5 F shaft and an 8F distal section, Sterile.

St. Jude Medical, Atrial Fibrillation Division, Inc.

NeuMoDx Cartridge-used for extraction, purification, amplification and detection of nucleic acids on the NeuMoDx 288 and

NeuMoDx Molecular Inc

Fresh Roast Systems ColorTrack. Model Name: ColorTrack. Model Number: BENCH R-100

Fresh Roast Systems Inc

mint Lesion, Software Versions: 3.9.0 through 3.9.5.

Mint Medical GmbH

Sterile Procedural Trays, labeled as the following: a. MAJOR CDS-LF b. BURN PACK-LF c. BURN PACK d. SMALL BURN

MEDLINE INDUSTRIES, LP - Northfield

Custom procedural convenience kits and trays, cardiac, labeled as: a) CENTRAL LINE INSERTION PACK, kit number LLCE52;

American Contract Systems, Inc.

Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1

Medtronic Perfusion Systems

smiths medical medex CBSS-5ML, Single Set, (172/15cm), Model Number DPSHC0093

Smiths Medical ASD Inc.

Syringes with exchangeable needles labeled as: SOL-CARE: 1) SOL-CARE 10ml Luer Lock Syringe w/Safety Needle 21G*1

Sol-Millennium Medical Inc.

AQUATECH PLUS 1 DAY TORIC Power: -07.50 -0.75/060 Daily Disposable Contact Lens with UV blocker

CooperVision Inc.

BF-XP60 OES Bronchofiberscope, Model No. BF-XP60

Olympus Corporation of the Americas

Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781060

TELEFLEX LLC

Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator, SAM 360P fully automatic defibrillator, SAM 500P semi-

HeartSine Technologies Ltd

SIGNA Voyager, with affected software versions: PX26.0 to PX26.6, VX28.0, VX29.1, VX29.2, MR30.0, MR30.1; Nuclear Magne

GE Medical Systems, LLC

Cardinal Health Presource Kits: 1 ) KIT, FETAL SURGERY, Catalog Number PB11FSC10 2 ) KIT, FETAL SURGERY , Catalog Numb

Cardinal Health 200, LLC

Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MS, Part ID 17197

BioPro, Inc.

RayStation with the following product descriptions: 1. RayStation 9B, Software Version: 9.1.0.933. 2. RayStation

RAYSEARCH LABORATORIES AB

TERUMO 60" TUBE SET W/HIGH CRACK CHK VLV, Article No. 7S3070. Singapore only. IV injection set.

B. Braun Medical, Inc.

CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K

Medtronic Sofamor Danek USA, Inc

Accessory Sets Syringes: 6ml syringe with a female luer with 15cm sealed SCD tubing, REF: RF-T15, and 60ml syringe on a

OriGen Biomedical, Inc.

EPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE¿ device is a user controlled, stereotactic accessory int

QUANTUM SURGICAL SAS

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:

Zimmer, Inc.