Medical Device Recalls

iNSitu Bipolar Hip System, Bipolar head implant Part ID Description 10-22-0038 Bipolar Head Assembly, Size 38mm 10-

Theken Companies LLC

iLet Bionic Pancreas, REF: BB1001

Beta Bionics, Inc.

Femoral Resurfacing Cup - (xx)MM, Ti-6AI-4V ELI, TiN CERAMIC W/ PLASMA SPRAY, STERILEEO, Reference Numbers: 01-03-0042 0

Synovo Production

VITROS XT 7600 Integrated System, Catalog No. 6844461

Ortho-Clinical Diagnostics, Inc.

Olympus Thunderbeat, 5 mm, 20 cm, Inline Grip

Olympus Corporation of the Americas

TourniKwik Tourniquet Set (CFN 79012)

Medtronic Perfusion Systems

Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid Amplification Test Assay

Meridian Bioscience Inc

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000477;

Beaver Visitec International, Inc.

Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080050

TELEFLEX LLC

MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, Kit REF: 8888340637

Covidien LP

CritiCool, thermoregulation device

Belmont Instrument Corporation

LABOR & DELIVERY PPS , Model No LLLD64O LLLD64O-01 LLLD64O-02

American Contract Systems Inc

Medline Convenience kits labeled as: 1) CHEST TUBE INSERTION TRAY, Pack Number DYNDA2063; 2) PULL D/C PACK, Pack Nu

MEDLINE INDUSTRIES, LP - Northfield

St. Jude Medical Agilis NxT Steerable Introducer, REF 408309

St. Jude Medical

Medline Convenience Kits: 1) ARTHROSCOPY CDS, Model Number: CDS984609B; 2) ARTHROSCOPY TRAYS, Model Number: DYNJ22501

Medline Industries, LP

GS SALINE SOLUTION 12FL OZ, SKU 902274

Family Dollar Stores, Llc.

Burlington Medical, Demi Half Aprons.

Burlington Medical, LLC

BEQ-HMO 50000-USA/ QUADROX-i Small, Oxygenator used during cardiopulmonary bypass Item no. 701067905

Maquet Medical Systems USA

VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064

Accriva Diagnostics, Inc.

AW-S030 NEO SONARMED SENSOR 3.0MM. Used in conjunction with SonarMed Monitor for airway monitoring.

SonarMed Inc

PPM LOMBARD PRODUCTS TSA 3P W NEUTRALIZERS 100 PLT, CATALOG 419014

Biomerieux Inc

Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample preparation tools for use with the

SIGHT DIAGNOSTICS LTD

BioFire Blood Culture Identification 2 (BCID2) Panel Part No: RFIT-ASY-0147 UDI: 00815381020338 Blood Culture Catalog N

BioFire Diagnostics, LLC

MEDLINE MAXORB EXTRA ALGINATE WOUND DRESSING 4X4 SQUARE REF MSC7044EP MEDLINE MOXORB EXTRA ALBINATE WOUND DRESSING 4X8

Advanced Medical Solutions Ltd.

Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;

Straumann USA LLC

TRVL KIT TOTHBRSH CAP PASTE IN POUCH 1CT, SKU 900737

Family Dollar Stores, Llc.

Combined Spinal and Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN 27 Ga. x

B BRAUN MEDICAL INC

Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy

Elekta Inc

B¿R¿A¿H¿M¿S KRYPTOR compact REACT, REF: 89986, used with B¿R¿A¿H¿M¿S PlGF Plus KRYPTOR, REF: 859075N, and run on the B¿R

Brahms GmbH

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001025;

Beaver Visitec International, Inc.