Medical Device Recalls

Medline Convenience kits containing recalled Swan-Ganz Catheters CABG A CDS CDS982269K CDS982269L CDS982269M

Medline Industries, LP

DURAMAX STACKED TIP 28CM STR. BASIC KIT, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialy

Angiodynamics, Inc.

AFT (Allograft Filler Tube) Straight Tube (1/2 Filled), Product Code 227010 (bone void filler)

Musculoskeletal Transplant Foundation, Inc.

LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 50 MM Item Number: 15-2030/08

Linkbio Corp.

V.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTDEV01 The 3M" V.A.C.¿ Ulta Negative Pressure Wound Therapy System is an

KCI USA, INC.

Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: EUOR002-06

AVID Medical, Inc.

Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PC424, b) 20-PC448, c) 20-PC548, d) 2

Advance Medical Designs, Inc.

Hobbs Biliary Pigtail Stent Kits Catalog Number: 6104

Hobbs Medical, Inc.

BD BBL Sensi Disc Ciprofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231657

Becton Dickinson & Co.

Philips C5-1 Transducer.

Philips Ultrasound, Inc

Merlin@home Transmitter REF EX1100 The Merlin@home" (M@h) transmitter is intended to transfer stored data from the p

Abbott Medical

Halyard LOWER EXTREMITY PACK - Medical convenience kits Model Number: PANJ001-03

AVID Medical, Inc.

O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask Product Code: 47117

O&M HALYARD, INC.

i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

Abbott Point Of Care Inc.

I.T.S. Fibula Plate PROlock with Angular Stability with the below descriptions and corresponding article numbers. 1.

I.T.S. GmbH

MEDLINE UNNA-Z STRETCH ZINC PASTE BANDAGE, REF NONUNNAS40 KOB article #40307010

KOB GmbH

REGARD Ultrasound Tray

ROi CPS LLC

ICU Medical ChemoLock Bag Spike REF: CL-10

ICU Medical, Inc.

SAFE-T-FILL Magnetic Rings for SAFE-T-FILL Blood Gas Capillaries, Model 07 9502

ASP Global, LLC. dba Anatomy Supply Partners, LLC.

Sedecal Mobile Digital Diagnostic X-Ray Systems; SM-40HF-B-D-KM (AeroDR X30)

SEDECAL SA

CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 5" (12.7CM) DEEP STERRAD COMPATIBLE, REF CD2-5S

Carefusion 2200 Inc

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. VASC

MEDLINE INDUSTRIES, LP - Northfield

ICD-VR DVMD3D4 PRIMO MRI, Model Number DVMD3D4; Implantable Cardioverter Defibrillators

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Medline Convenience kits used for various procedures: 1) CUSTOM BLOCK KEMP PACK-LF, Model Number: DYNJ0371999G;

MEDLINE INDUSTRIES, LP - Northfield

Allura Xper FD20 Biplane OR Table Product Codes: (1)722020, (2) 722025; Associated 510(k) numbers: K102005, K130842, K13

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Philips Allura Xper FD series with Software Version Number: 2.1.x- intended for Vascular, cardiovascular and neurovascul

Philips North America Llc

BeneVision N1 Patient Monitor (N1). Part Numbers: 6660E-PA00017, 6660E-PA00014, 6660E-PA00012, 6660E-PA00011, 6660E-PA00

Mindray DS USA, Inc. dba Mindray North America

Synchro .014"guide wire, 35 cm tip, Catalog: M00313010 Synchro .014 guide wire, 300 cm length, Catalog: M00313310 SYNC

Stryker Neurovascular

Product Name: Ingenia 1.5T S; Model Number: 781347;

Philips North America Llc

Karl Storz - Endoskope , REF: 27294AA, Hopkins Telescope 6, 18 Fr, Rx only, CE 0123

Karl Storz Endoscopy