Medical Device Recalls

HAND PACK-Procedure Kit Catalog Number: WEHD16C

American Contract Systems Inc

Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795116, 100-240V -, 50/60 Hz, 500 VA, CE2797, Rx Only,

Philips Ultrasound Inc

CRT-D DTBC2D1 BRAVA IS1/DF1 INTL, Model Number DTBC2D1; Implantable Cardioverter Defibrillators

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

Stryker SWANSON Flexspan Finger Joint Implant W/O Grommets Silicone, Size: 00, REF 4700020, Sterile.

Wright Medical Technology, Inc.

Allura Xper FD10 OR Table Product Codes: (1)722022, (2) 722033; Associated 510(k) numbers: K102005, K130842, K130638, K1

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Medline Fluid Delivery Set with Drip Chamber: 1) MTO,135,YELLOW,MICRO,SPK-MAIMONIDES, Item Number: 60130527; 2) MTO,

MEDLINE INDUSTRIES, LP - Northfield

Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237.

Philips Medical Systems (Cleveland) Inc

Palindrome Precision Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.

Mozarc Medical US LLC

ActiveAid 922, Shower/Commode Chair

Altimate Medical, Inc.

High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx Only, CE 0123

Percussionaire Corporation

DDU-100 Lifeline Automated External Defibrillator (AED)-Indicated for use on victims of sudden cardiac arrest

Defibtech, LLC

Vivo 45 LS, pressure and volume ventilator capable of delivering continuous or intermittent ventilatory support for pati

Breas Medical, Inc.

TRUMATCH CT PIN GUIDE KIT R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical

DePuy Orthopaedics, Inc.

Software version 5.3 in: RAPIDPoint 500e Blood Gas System (USA) Siemens Material Number: 11416751 RAPIDPoint 500e

Siemens Healthcare Diagnostics Inc

Brand Name: Atlan Product Name: Atlan A300XL Model/Catalog Number: 8621400 The Atlan is an anesthesia workstatio

Draeger Medical, Inc.

Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max

Siemens Medical Solutions USA, Inc

Medline convenience kit: SMSC-PELVISCOPY PACK-LF DYNJ0161619M

Medline Industries, LP

QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3-E, Order Number G22766; used to dilate strictures of the biliary tree

Wilson-Cook Medical Inc.

VERICIS, Merge Cardio, Model/Catalog Number: Version 9.x, Software Version: 9.0.6 and 9.0.8; VERICIS is an integrated ca

Merge Healthcare, Inc.

MEDLINE BLOOD CULTURE COLLECTION KIT, Reorder Number DYNDH1714A

MEDLINE INDUSTRIES, LP - Northfield

HENRY SCHEIN, UNIVERSAL TRAY, Item No.570-2787

Stradis Medical, LLC dba Stradis Healthcare

Lactose Intolerance Test

GET TESTED INTERNATIONAL AB

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS4 (5PK), REF H74908526575A2; cardiac catheter

Boston Scientific Corporation

Medline medical procedure convenience kits labeled as: 1) BREAST-HERNIA-PORT CDS-LF, Kit SKU CDS984853L; 2) BREAST

Medline Industries, LP

Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm, 35 cm, Front

Olympus Corporation of the Americas

Foundation Kit

Stradis Medical, LLC dba Stradis Healthcare

Medline Convenience kits used for various procedures: 1) RHINOPLASTY PACK, Model Number: DYNJ84116A

MEDLINE INDUSTRIES, LP - Northfield

CardioQuip Modular Cooler-Heater, Model: MCH-1000(i), Power: 115V-60Hz, 16A

CardioQuip, LLC

Plus 30 Priority Pack w/.096 RHV - REF 1000183 WPL2122277-01 (20-03-01) Plus 30 Priority Pack w/.115 RHV - REF 100018

Abbott Vascular

Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-0

Datascope Corp.