Medical Device Recalls

CombiDiagnost R90 R.1.0

Philips North America

Exactech Equinoxe Shoulder System, Catalog Numbers: a) 314-23-02, b) 314-23-03, c) 314-23-13, d) 314-23-14, e

Exactech, Inc.

MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY-LF, REF CDS760059I; 2) GYN LAPAROSCOPY CDS #34-RF, REF CDS9

MEDLINE INDUSTRIES, LP - Northfield

The Optima Coil System consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to a

BALT USA, LLC

Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.

Siemens Healthcare Diagnostics, Inc.

Allura CV20; Product Code: 722031; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

STRADIS HEALTHCARE, Vein, Item No.682-1732,

Stradis Medical, LLC dba Stradis Healthcare

Welch Allyn 2-Piece Reusable Blood Pressure Cuff Kits labeled as: 1. WELCH ALLYN 2-Piece Reusable Blood Pressure Cuff

Baxter Healthcare Corporation

Product: STA Liatest D-Di; REF: 00515;

Diagnostica Stago, Inc.

Endo Surgical Navigation Advanced Platform Patient Engagement (EndoSNAP), software version SNP.1.12.0, imaging processin

Surgical Theater Inc

ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)

ICU Medical, Inc.

Colonoscope, Model Number PCF-H180AL.

Olympus Corporation of the Americas

Allia Moveo angiographic X-ray system

GE Medical Systems, LLC

Surgidac Uncoated Braided Polyester suture Product Description D-1764K SURGIDAC* 5-0 WHI 45CM SS24DA

Covidien, LP

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

B Braun Medical Inc

Nextra Hammertoe Correction System Driver SKU: NX-DR Orthopedic surgical instrument

Nextremity Solutions

Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536;

Siemens Healthcare Diagnostics, Inc.

MEDLINE HEART CABG CDS, REF CDS983376R

MEDLINE INDUSTRIES, LP - Northfield

BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILMARRAY systems, IVD, Rx Only

BioFire Diagnostics, LLC

Baxter TruSystem 7500 Hybrid (SC), Product Code 1854086

Baxter Healthcare Corporation

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CHN

MEDLINE INDUSTRIES, LP - Northfield

Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 70 MM Item Number: 11-301331

Biomet, Inc.

Brand Name: Osteotec Product Name: Osteotec Silicone Finger Implant Model/Catalog Number: OSTF-3 (Sz. 3), OSTF-4 (Sz.

Osteotec Limited

Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-32-XX, Novation

Exactech, Inc.

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001212;

Beaver Visitec International, Inc.

Stryker Sustainability Solution Color Cuff 24" (Yellow) Quick Connect Dual Port Single Bladder REF 5921-024-235 Stryk

Stryker Sustainability Solutions

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001526;

Beaver Visitec International, Inc.

VIDAS Lyme IgG II (LYM), REF 417401

bioMerieux, Inc.

11272V CMOS VIDEO-CYSTO-URETHROSCOPE REV 11272VA 11272VAK CMOS VIDEO-CYSTO-URETHROSCOPE REV; 11272VU 11272VUK CMOS

Karl Storz Endoscopy

Medline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069G; 2) CHP COCHLEAR SUPPLEMENT CDS, M

Medline Industries, LP