Medical Device Recalls

Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 23 cm, Item Code 8888541023

Covidien, LP

Olympus Resection Sheath, 26 Fr. with Deflecting Obturator; Model No. A22042T. Resection sheath for urologic application

Olympus Corporation of the Americas

Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) SPINAL ANESTHESIA TRAY-LF,

Medline Industries, LP

Arrow Pacing Catheter Kit-Bipolar Electrode Catheter 5 Fr. 110 cm, Product Code: AI-05210 - Product Usage: intended for

Arrow International Inc

Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-11, STERILE EO, Rx Only *EU Distribution only

Merit Medical Systems, Inc.

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001157;

Beaver Visitec International, Inc.

FLIXENE, 7X80, 1GDS, GW. Single-Ended Slider GDS. Vascular graft

Atrium Medical Corporation

McKesson PREVENT HT Safety Winged Blood Collection Needle with Tube Holder, MFR # 16-NBCH21GS

Zhejiang Kindly Medical Devices Co., Ltd.

BD SmartSite Bag Access Device, REF: 2300E-0500; BD BAG ACCESS DEVICE CHECK VALVE SmartSite VALVE, REF: 2309E

CAREFUSION

HemosIL ReadiPlasTin, Part No. 0020301400

Instrumentation Laboratory

a. Hillrom Centrella Smart+ Medical-Surgical Hospital Bed, Product codes: P7900B000001, P7900B100010, P7900B100024, P7

Baxter Healthcare Corporation

Microalbumin Calibrator Series (mALB CAL)-IVD to calibrate the Microalbumin Assay Catalog Number: MA2426

Randox Laboratories Ltd.

STRADIS HEALTHCARE, Surg, Item No.40551TMS. oral surgery tray

Stradis Medical, LLC dba Stradis Healthcare

GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 610 A1, REF 1012-9620-222;

GE Medical Systems China Co., Ltd.

Brand Name: VITROS; Product Name: VITROS XT 7600 Integrated System; Model/Catalog Number: (1) 6844461, (2) 6272222; S

Ortho-Clinical Diagnostics, Inc.

Food Sensitivity Test Large

GET TESTED INTERNATIONAL AB

Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 134-28-XX, Acumatch

Exactech, Inc.

2008T BlueStar Hemodialysis Machine, Model 191124 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.

Fresenius Medical Care Holdings, Inc.

DeRoyal TOTAL HIP PACK, REF 89-9113.06

DeRoyal Industries Inc

Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614

C.R. Bard Inc

PERI-GUARD SUPPLE, Product Codes: a) SPG1016: 10X16 CM US, TS; b) SPG0404: 4 X 4 CM US, TS; c) SPG0608: 6 X 8

Baxter Healthcare Corporation

VITROS Chemistry Products HbA1c Reagent Kit- IVD for the quantitative determination of percent glycated hemoglobin A1c (

Ortho-Clinical Diagnostics, Inc.

Optikon Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: OPT14-5011. Product Description: The Disposable Micro

Kirwan Surgical Products, LLC

DigitalDiagnost C90 Release 3.1, used to acquire, process, store, display and export digital radiographic images.

Philips North America Llc

GE Healthcare Revolution Advance, Model number 5849504; X-ray/computed tomography systems

GE Healthcare (China) Co., Ltd.

Power-PRO 2- A powered ambulance cot that consists of a platform, including a mattress, mounted on a wheeled, retractabl

Stryker Medical Division of Stryker Corporation

Injection needle, bayonet, Luer-Lock, 1. Model no. 50-353-23, working length 25 cm, total length 31cm, nonsterile;

Spiggle & Theis Mt Gmbh

Medline Convenience Kits: 1) NAIL KIT, Model Number: DYKM1528

Medline Industries, LP

Product Name: TOTALPLUS,25+ 7.5CPM VALV WD6 Model/Catalog Number: 8065751618 Software Version: N/A Component: N/A

Alcon Research LLC

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001818;

Beaver Visitec International, Inc.