Medical Device Recalls

Dimension Vista LOCI CA 15-3 Flex reagent cartridge. In Vitro Diagnostic for the quantitative measurement of CA 15-3.

Siemens Healthcare Diagnostics, Inc.

DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12115 LV VENT 15FR, Model Number 12115

Medtronic Perfusion Systems

Brand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog Number: 1491950C4US Software Version: firmw

LEICA BIOSYSTEMS NUSSLOCH GMBH

Citrasate, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-2251-CA, 08-3251-CA, 13-2251-CA;

Fresenius Medical Care Renal Therapies Group, LLC

ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultra

ImaCor Inc.

MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System; Catalog number: FLEXS-150-QFT;

Bayer Medical Care, Inc.

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001395;

Beaver Visitec International, Inc.

RX CHOLANGIOGRAM KIT Material Numbers: M00575241 M00575281 M00575321 M00575361 M00575381 M00575401 M00575441

Boston Scientific Corporation

3M Steri-Drape, Medium Drape with Adhesive Aperture, REF 1030NS, general surgery drape

3M Healthcare Business

RX Imola-IVD Clinical Chemistry Analyzer Catalog Number: RX4900. RX4900R (refurbished)

Randox Laboratories Ltd.

Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 12 MM, 83 MM Long Item Number: 113632

Biomet, Inc.

DBX Demineralized Bone Matrix Putty 10cc-Indicated for treatment of surgically created osseous defects or osseous defect

Musculoskeletal Transplant Foundation, Inc.

Freeman Pancreatic Flexi-Stent Catalog Number: 6567

Hobbs Medical, Inc.

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

B Braun Medical Inc

Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638,

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

HENRY SCHEIN, VEIN TRAY, Item No.570-2738,

Stradis Medical, LLC dba Stradis Healthcare

Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-10 Software Version: All software v

Abbott Laboratories

regard FOOT PACK, OR00123Y, Item Number 880118; orthopedic surgery convenience kit

ROi CPS LLC

smiths medical portex BLUgriggs Percutaneous Dilation Procedural Trays with BLUselect tracheotomy tubes, labeled as foll

Smiths Medical ASD Inc.

DeRoyal CHILDREN'S GENERAL TRACEPACK, REF 89-9342-06

DeRoyal Industries Inc

SmartPath to dStream for 1.5T

Philips North America Llc

HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004

Access Vascular, Inc

Signature Laparoscopic Instruments, Debakey Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connect

Silex Medical, LLC

BIOMET TRAUMA A.L.P.S. FIBULA COMPOSITE LOCKING PLATE 8 HOLE, Item # 856204008. Devices are packaged in a vacuum sealed

Biomet, Inc.

Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Luer Intubated Ad

Oridion Medical 1987 Ltd.

Brand Name: MPR Product Name:DISPOSABLE TOURNIQUET CUFF 20" DUAL BLADDER, 2 LINE (10) Model/Catalog Number: DB-7020-02

ASP Global, LLC.

GE Healthcare Revolution Ascend Elite, Model Number 6967000-100; X-ray/computed tomography system

GE Healthcare (China) Co., Ltd.

DEX Ophthalmic Tissue Forceps, 25ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-25

Katalyst Surgical, LLC

Entuit Secure Adjustable Gastrointestinal Suture Anchor Set - Intended for anchoring the anterior wall of the stomach to

Cook Incorporated

DigitalDiagnost C90 High Performance, used to acquire, process, store, display and export digital radiographic images.

Philips North America Llc