Medical Device Recalls

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.

Cortoss Bone Augmentation Material 5cc Cartridge, Catalog Number 2101-0005, GTIN 00808232000962

Stryker Spine

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 PlGF Plus KRYPTOR, Catalog Number: 859075N. in vitro diagnostic test for Placental Growth Factor

Brahms GmbH

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

Beaver Visitec International, Inc.

Ivalon CELLULOSE SURGICAL SPEAR- Intended To Be Used During Ophthalmic Surgical Procedures For Fluid Management Mode

Carwild Corporation

Monoject(TM) 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, Model Number/Product Code: 1180100777

Cardinal Health 200, LLC

Trevo Trak 21 Microcatheter, Catalog: 90338

Stryker Neurovascular

Alinity m Integrated Reaction Units (IRU)

Abbott Molecular, Inc.

Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Bio

Medtronic Perfusion Systems

Propel Mini Mometasone Furoate Sinus Implant, with Straight Delivery System, REF 60044

Intersect ENT, Inc.

HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II Sealed Outflow Graft with Bend Relief REF 103393 2

Thoratec Corp.