Medical Device Recalls

DeRoyal NEURO SPINE BACK PACK PGYBK, REF 89-10853.01

DeRoyal Industries Inc

Freeman Pancreatic Flexi-Stent Kit (containing 6566) Catalog Number: 6518

Hobbs Medical, Inc.

Ventstar Coax 180, MP03374

Draeger Medical, Inc.

Infection Control (IC) Lifting Strap used with the following Cirrus and Pinnacle Ceiling Lifts: Cirrus 450, Cirrus 600,

Tollos

MEDLINE LUER LOCK DISPOSABLE SYRINGE WITHOUT NEEDLE, REF SYR101010

MEDLINE INDUSTRIES, LP - Northfield

ADVANTA VXT, 8X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft

Atrium Medical Corporation

Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TNG-4007-6pk.

TANGENT ENDOSCOPY, LLC

MAGNETOM Verio Dot Upgrade. Model Number: 10684334.

Siemens Medical Solutions USA, Inc

QUADROX-iR, used during cardiopulmonary bypass Model Item No. Description BEQ-H

Maquet Medical Systems USA

Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S.

Stryker GmbH

Nail Insertion Sleeve, elastic T2 Tibia SPI ¿8-13 (SPI Elast. Sleeve 8-13), Catalog Number 18061407S

Stryker GmbH

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001019;

Beaver Visitec International, Inc.

ZPLP(Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 10 Holes, 158 MM, Sterile- Indicate

Zimmer, Inc.

Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Filter, Suitable of Jugular or Femoral Deliver

Argon Medical Devices, Inc

Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN917288), cardiac pump

ARROW INTERNATIONAL Inc.

InSure ONE Fecal Immunochemical Test. Labeled as follows: 1. Insure ONE POL Patient Kit - 10 pack. Model Number: 9001

Enterix, Inc.

BD BBL CultureSwab EZ Collection and Transport System, REF 220144, in vitro Diagnostic, SterileR, Rx Only

Copan Italia

SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C

FUJIFILM Healthcare Americas Corporation

Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPW-35-150 ORDER NUMBER (GPN):G56149. For

Cook Incorporated

Phantom TTC Nail, TTC Nail, 11.5 X 250mm, RIGHT, REF: P31-615-250R

Paragon 28, Inc.

Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test)

Siemens Healthcare Diagnostics, Inc.

Disposable Spetzler-Malis Bipolar forceps, 20CM SM DISP BAYONET 0.5MM TIP, Catalog Number 6760-200-005

Stryker Corporation

See RES description

MEDLINE INDUSTRIES, LP - Northfield

INFX-8000V. For radiographic and fluoroscopic studies and intervention.

Canon Medical System, USA, INC.

Venous probe connection cable (REF 701069333 and 701048804) used with the Cardiohelp-i System, part numbers 701072780 an

Maquet Medical Systems USA

Bard Marquee Disposable Core Biopsy Instrument Kit: BARD MARQUEE KIT 12G X 10 CM, REF: MQK1210; BARD MARQUEE 12G X 10

Bard Peripheral Vascular Inc

20/30 INDEFLATOR -REF 1000184 WPL2122268-01 (2019-03-01)

Abbott Vascular

ICU Medical 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connector, Rotating Luer, REF: CL-3950

ICU Medical, Inc.

ECONO STERILE medical procedure kits labeled as: ECONO STERILE SCALPEL HDL #3 W/METRIC CS/25, Model Number 96-3500M

Sklar Instruments

Leaky Gut Test

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