Medical Device Recalls

THERASPHERE ADMIN SET, Article No. 7M2650. Canada only. Sterile, single use administration set used to deliver Yttrium-

B. Braun Medical, Inc.

RIGHT CORONAL BENDER, TEK1940. Instrument used during spinal surgery.

Aesculap Implant Systems LLC

DeRoyal SHOULDER ARTHOSCOPY PACK, REF 89-9946.04

DeRoyal Industries Inc

SIGNA MR380, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ImaCor ultrasound diagnostic platforms. Mo

ImaCor Inc.

Paracentesis Thoracente, SLPT76H; Medical convenience kit

American Contract Systems, Inc.

Medline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE1455B; 2) GI LAB OTHER ENDO KIT, Model Numb

Medline Industries, LP

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VNUS TRAY, Model Number DYNJ44

MEDLINE INDUSTRIES, LP - Northfield

DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK236SU. For use in laparoscopic procedures.

Aesculap Inc

Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier II Model/Catalog Nu

Ortho-Clinical Diagnostics, Inc.

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000921;

Beaver Visitec International, Inc.

CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic ba

Datascope Corp.

GE Healthcare Carestation 620 SE, Model/REF Number 1012-9620-012. Anesthesia system.

GE Medical Systems China Co., Ltd.

HYDRATOME RX 44-20MM/260CM Material Number: M00583040

Boston Scientific Corporation

Medline medical procedure convenience kits labeled as: 1) C-SECTION PACK, Kit SKU DYNJ35494C; 2) SMJ C-SECTION PACK

Medline Industries, LP

GE Healthcare Centricity PACS-IW (PACS-IW), Model Numbers: 1) 2042988-001; 2) 2049587-009; 3) 2049587-011; 4) 2

GE Healthcare

Achieva 3.0T, Model No. 781177

Philips North America

SENTIERO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098

PATH

Allura Xper FD20 OR Table Product Codes: (1)722023, (2) 722035, (3) 722015; Associated 510(k) numbers: K102005, K130842,

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Ventriculostomy Kit, REF: 46154

Medtronic Neurosurgery

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

B Braun Medical Inc

Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm

ConvaTec, Inc

CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, Plus 4-Way Stopcock Extensio

Baxter Healthcare Corporation

CombiDiagnost R90 R1.1

Philips North America

HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, Handle only, with Cojoined Suction an

Davol, Inc.

Convatec, EsteemBody Drainable Pouch REF:423653 10-35mm

ConvaTec, Inc

Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Mod

Alcon Research LLC

Jiffy Original Composite Polisher Cups (Coarse) 12pk, REF 7011.

Ultradent Products, Inc.

Brand Name: Quantum Informatics - VIPER Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or

Spectrum Medical Ltd.

Ratcheting Screwdriver Handle, provided in the Aequalis Perform Reversed kit

Tornier, Inc