Medical Device Recalls

CLARAVUE Pre-wired Electrode IP-SET N3 - PEDIATRIC-US Model: 32028776 50401-US

Graphic Controls Acquisition Corporation

Medline procedural kits labeled as: 1) BABY ADMIT, Pack Number DYKB1011C; 2) BABY ADMIT KIT W/ PAMPERS, Pack Number

MEDLINE INDUSTRIES, LP - Northfield

Thermo scientific MAS Omni CARDIO, Liquid Assayed Integrated Cardiac Control, Model/Catalog Number: OCRD-L, OCRD-101, OC

Microgenics Corporation

Surgical convenience kits labeled as: MEDLINE PLASTICS/PEDS KIT, Reorder Number DYNDA2489

MEDLINE INDUSTRIES, LP - Northfield

Neurotransmitters Basic

GET TESTED INTERNATIONAL AB

Brand Name: Vial2Bag Advanced¿ Product Name: Vial2Bag Advanced¿ 20mm Admixture Device Model/Catalog Number: 6070030 S

West Pharmaceutical Services AZ, Inc.

Centurion STERILE TRACH BRUSH, Product Code 6225ST

MEDLINE INDUSTRIES, LP - Northfield

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM EU + ROW; the system utilizes an interacti

Boston Scientific Corporation

SPRYSTEP VECTOR, Custom made device dynamic ankle-foot orthosis (AFO) , Reference numbers: 17V1030, 17V2030, 17V1031, 1

Townsend Design

GE Healthcare CARESCAPE Central Station (CSCS) V2.0x MAI700 (Integrated), REF 2082278-001, and MAS700 (Desktop, REF 2082

GE Healthcare, LLC

Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601 (IPN001109), cardiac pump

ARROW INTERNATIONAL Inc.

Access Testosterone assay, Catalog Number 33560

Beckman Coulter, Inc.

AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm; Material Number (UPN): M00553690;

Boston Scientific Corporation

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

B Braun Medical Inc

Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat swabs.

Altruan GmbH

Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700REA Software V

SunMed Holdings, LLC

Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-HFWC containing components: PT-65

TELEFLEX MEDICAL INC

Catalog A399400A, SureStep" Foley Tray, Add-a-Foley, Complete Care", Drainage Bag, StatLock" Stabilization Device

C.R. Bard Inc

LGX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404450 (12CM PS IZ), (2) 72404451 (15CM PS IZ), (3)

Boston Scientific Corporation

Medline Convenience Kits: 1) CHEST/BREAST-LF, Model Number: DYNJ83950

Medline Industries, LP

ARTIS icono (ceiling configuration), Fluoroscopic x-ray system; Model no. 11328100

Siemens Medical Solutions USA, Inc

Beckman Coulter Access Free T3, Triiodothyronine, Free, Catalog #A13422, each box contains 2 reagent packs.

Beckman Coulter, Inc.

BACTEC 9120 System Version or Model: 445570 Catalog Number: 445570

Becton Dickinson & Co.

LH One Step Ovulation Test Device (Urine)

Changchun Wancheng Bio-Electron Co., Ltd.

GORE ACUSEAL Vascular Graft, REF: ECH050020J, ECH050020W, ECH050050J, ECH050050W, ECH060010A, ECH060020A, ECH060020J, EC

W L Gore & Associates, Inc.

ENT, COEN27N; Medical convenience kit

American Contract Systems, Inc.

Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0

FujiFilm Healthcare Americas Corporation

Medline brand medical procedure convenience kits, labeled as: a) OB PACK-LF, REF DYNJ0912449M; b) OB PACK, REF DYNJ

MEDLINE INDUSTRIES, LP - Northfield

Monterey AL Implant Inserter; 22mm; Catalog 48019140.

Stryker Spine

Infusomat SPACE PUMP IV SET, 2 CARESITES, ASV-Used with an electrically-powered infusion pump for intravenous (IV) admin

B. Braun Medical, Inc.