Medical Device Recalls

Description/REF: EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05502-VM1; EPIDURAL CATHETERIZATION KIT: 19 GA/AK-05501; EP

ARROW INTERNATIONAL, LLC

progenamatrix Human Keratin Matrix, sterile, Rx, with the following model numbers: (1) PM2012, 12 x 2 cm; (2) PM3002, 2

ProgenaCare

ICD-DR DDBB2D4 EVERA XT IS1/DF4 INTL, Model Number DDBB2D4; Implantable Cardioverter Defibrillators

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

Calibrate (80 kVp) nanoDot D2DNS, Model Numbers: a) 18120-000; b) 18120-KIT; c) 18120-SET; radiation monitoring d

Landauer

Nova Stat Profile Prime Plus POC Analyzer (CE)-Intended to measure certain gases in blood, serum, plasma or pH of blood,

Nova Biomedical Corporation

HENRY SCHEIN, LOOP RECORDER PACK, Item No.570-2891

Stradis Medical, LLC dba Stradis Healthcare

Heartstring III Proximal Seal System. Intravascular anastomosis occluder.

Maquet Cardiovascular, LLC

SOLTIVE SuperPulsed Laser Fibers Model Numbers TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TFL-FBX550S, TFL-FBX940S, TFL-FBX

Olympus Corporation of the Americas

Infusomat UNIV. 60 DROP PUMP SET, 2 CARESITES, ASV-Used with an electrically-powered infusion pump for intravenous (IV)

B. Braun Medical, Inc.

3.0 Liter Disposable Set (4 sets/case). Model Number: 903-00032. The P/N 903-00032 consists of 4 Large Volume Rese

Belmont Instrument LLC

REF: 666289 , BD FACS, 7-Color Setup Beads, 25 Runs, CE, IVD. Used in flow cytometry for fluorescence compensation.

Becton, Dickinson and Company, BD Bio Sciences

Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380065

TELEFLEX LLC

Philips Allura Xper FD10 system with an ADN7NT patient table. Model Number: 722010, Software Version Number 8.1.100.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

t:slim X2 Insulin Pump with Interoperable Technology

Tandem Diabetes Care, Inc.

The Medline General Surgery Tray is customized to meet requirements of the hospitals and health care professionals utili

MEDLINE INDUSTRIES, LP - Northfield

Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog Number: MAJ-891. This instrument is design

Olympus Corporation of the Americas

Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) BLOCK TRAY, Medline Kit

Medline Industries, LP

Box as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quantity 1 Box of 3 Systems. Kit as labeled: R

CooperSurgical, Inc.

Blood Agar,5% Sheep Blood 100/PK, Product Number R01202

Remel, Inc

Baxter prismaflex, HF 1000 PAES membrane, REF 107140 Used with Prismaflex or PrisMax control units for continuous fl

Baxter Healthcare Corporation

Apellis Injection Kit 29g Injection Needle -single use intended to inject fluids into, or withdraw fluids from, parts of

Apellis Pharmaceuticals, Inc.

Medline Convenience kits used for various procedures: 1) ED CRASH C-SECTION TRAY, Model Number: MNS13635A; 2) C-SECTI

MEDLINE INDUSTRIES, LP - Northfield

Otopore Square outer ear wound dressing, Firm Catalog Number 5400-020-100 and Forte Catalog Number 5400-020-100ITL

Stryker Corporation

Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm

Intuitive Surgical, Inc.

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

B Braun Medical Inc

Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 44 cm, Item Code 8888

Covidien, LP

SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000; SwabCap, 200-ct. Box, REF: SCXT3-200

ICU Medical, Inc.

Welch Allyn Connex Vital Signs Monitor (CVSM):

Baxter Healthcare Corporation

LIFEPAK 15, REF: 99577-000061, Part Number V15-2-000067

Physio-Control, Inc.

BF-3C160: EVIS EXERA Bronchovideoscope

Olympus Corporation of the Americas