Medical Device Recalls

20548 Vitale Silver calcium Alginate Dressings 4x8, 5/box

CellEra LLC

CardioTek EP-TRACER Software V2.x.

CardioTek BV

Olympus OER-Pro

Aizu Olympus Co., Ltd.

AcuTwist Acutrak Compression Screws Part Number/Part Description: AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw

Acumed LLC

Model Number 40KWFXPLUS, Mobile X-ray system

SEDECAL SA

CARESAFE utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space La

B Braun Medical Inc

Medline Convenience Kits: 1) SPINAL CDS, Model Number: CDS940087AG; 2) SPINAL CDS, Model Number: CDS940087AI; 3) TO

Medline Industries, LP

REV 2 Flowcell Capsule Spare, Part Number: C04154

Beckman Coulter, Inc.

ADVANTA VXT, 4-6X45, 1GDS, CH, TPR-SW. Single-Ended Slider GDS. Vascular graft

Atrium Medical Corporation

LACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07B

American Contract Systems Inc

regard VITRECTOMY PACK, EY00266H, Item Number 800028008; eye surgery convenience kit

ROi CPS LLC

Medline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035; 2) LVAD DRIVELINE TRAY, Model Number: DM1035A

Medline Industries, LP

MEDLINE Intermittent Latex Catheter Coude Pre-Connected to Collection Bag, 14 Fr, 1000mL, Medline Product Number/SKU (RE

Medline Industries, LP

biokitHSV-2 Rapid Test, REF: 300028001

Biokit, S.A.

wDR 2.2 Mobile Digital Diagnostic X-Ray System

SEDECAL SA

Surepulse VS Cap Extra Small REF: SP-159-A1 component of VS Newborn Heart Rate Monitor

SUREPULSE MEDICAL LTD

DxU 850m Iris Urine Microscopy Analyzer Catalog Number C49513, in-vitro diagnostic device, urine analysis

Beckman Coulter, Inc.

Edwards PediaSat Oximetry Catheter Set, REF: XT358KTP, Exterior Diameter 5.5F, Usable Length 8 cm, Number of Lumens: 3,

Edwards Lifesciences, LLC

LOWER EXTREMITY - 247542- Procedure tray Catalog Number: BFLE56X

American Contract Systems Inc

PrisMax System, Product Code 955626

Baxter Healthcare Corporation

Allen Advance Table, RSP-ADVANCE TABLE: a) REF A-71100-US, #107003, b) A-71101-EU, #107003. operating room table

Baxter Healthcare Corporation

VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridged

Greiner Bio-One North America, Inc.

L-Shaped Femoral Augment; Item Numbers: (1) 880-320/12 (Sz. 0 - cemented sm), (2) 880-320/22 (Sz. 0 - cemented lg), (3)

Waldemar Link GmbH & Co. KG (Mfg Site)

Catalog No. 8888160556; Umbilical Vessel Catheter 5 French dual lumen

Cardinal Health 200, LLC

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001331;

Beaver Visitec International, Inc.

VasoView HemoPro 2 Endoscopic Vessel Harvesting System. Model Numbers: VH-4000. Indicated for use in minimally invasive

Maquet Cardiovascular, LLC

Halyard MINOR PACK - Medical convenience kits Model Number: MMOK013-03

AVID Medical, Inc.

Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: CPB ADJUNCT PACK, DR. C

MEDLINE INDUSTRIES, LP - Northfield

a. ABBOTT RAPID DX N AMERICA LLC Alere Rapid Test Kit Alere Fertility Test hCG Pregnancy Test Urine Sample 30 Tests, Mod

Mckesson Medical-Surgical Inc. Corporate Office

SmartPath to dStream for XR and 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use a

Philips North America Llc