Medical Device Recalls

Panda Freestanding Warmer, Infant Radiant Warmer Product Identifiers: 2063568-001 Impacted only if service blender M109

Datex-Ohmeda Inc

Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723

Fisher & Paykel Healthcare, Ltd.

ET82HP OUTLOOK PUMP EXTENSION SET-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for

B. Braun Medical, Inc.

ICU Medical 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Purple Cap, Hanger

ICU Medical, Inc.

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001970;

Beaver Visitec International, Inc.

REX (Recovery Exercise X-Trainer) Pressure Therapy System- USER Manual. Intended to temporarily relieve minor muscle ach

Compass Health Brands (Corporate Office)

Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LOWER PELVIC PACK, kit

American Contract Systems, Inc.

ADVANTA VXT, 6X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft

Atrium Medical Corporation

regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009

ROi CPS LLC

Maquet Hanaulux 2006/ 2007, Blue 100, Blue 130/ 90, Blue Series 30/ 80, and Prismatic OR Light Systems. No Model Number

Getinge Usa Sales Inc

Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL), REF: TBPN67-60 For processing of clinical specimens

Immuno-Mycologics, Inc

LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325L

Microbiologics Inc

MEDLINE ReNewal Coblator II Evac 70 Xtra Plasma Wand,w/Integrated Saline Line & Integrated Cable, Item Number REF EICA5

MEDLINE INDUSTRIES, LP - Northfield

syngo.CT VA20A, VA30A and VA40A in: syngo.via RT Image Suite / Sim&Go SOMATOM go.Now SOMATOM go.Up SOMATOM go.A

Siemens Medical Solutions USA, Inc

Streptococcal A rapid test kits, labeled as: Wondfo Biotech Co., Ltd, WondView Strep A Test Kit, Guangzhou Wondfo Biote

Wondfo USA Co Ltd

Voyant 1-Day Premium Toric, (stenfilcon A) contact lens. Model Number: Voyant 1-Day Premium Toric. 54% water content,

CooperVision, Inc.

HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan¿ PAD (Public Access Defibr

HeartSine Technologies Ltd

QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 70000-USA

Maquet Medical Systems USA

SIGNA Architect, Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

LINK SLED Knee System: ENDO MODEL SLED TIBIAL COMP 11 MM X 45 MM Item Number: 15-2030/03

Linkbio Corp.

MED-810A Zemits NDPrime Laser products

Advance-Esthetic LLC

DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module, DxC 500i, Without ISE, REF: C6352; part

Beckman Coulter Inc.

Medline Convenience kits used for various procedures: 1) OCULOPLASTIC PICK PACK, Model Number: DYNJ43914B; 2) PLASTIC

MEDLINE INDUSTRIES, LP - Northfield

PARTIAL NEPHRECTOMY PACK. Medical convenience kit.

AVID Medical, Inc.

HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100

Heartware, Inc.

DURATION PLASTIC PATELLA-DURACON Intended for knee replacement Product Number: 6642-2-200

Howmedica Osteonics Corp.

medex TranStar DPT w/Two Stopcocks 10/EA, Product Code REF MX950X2SC

Smiths Medical ASD, Inc.

(1) Medline Sterile Maximum Barrier Pack-LF, Item DYNJ0248546C, 6 kits per case, contains BD Chloraprep Hi-Lite Orange,

MEDLINE INDUSTRIES, LP - Northfield

BD BBL Sensi Disc Cefixime - 5 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231664¿

Becton Dickinson & Co.

ZOLL, REF 8700-0781-14 (CL-2295CO), COOL LINE Intravascular Heat Exchange Catheter kit with central venous infusion capa

ZOLL Circulation, Inc.