Medical Device Recalls

Pregnancy Test

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Quidel Triage Cardiac Panel: REF: 97000HS, 97021HS (Troponin I), 97022HS (CK-MB and Troponin I), 97000HSEU, 97000HSEUJP,

QUIDEL CARDIOVASCULAR INC

RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement Product Number: 6637-0-831

Howmedica Osteonics Corp.

SCISSORS, OR, SHARP/BLUNT, 5.5", STERILE, Item Number DYND04000

Medline Industries, LP

IMPIX 3D, REF numbers: a) B242C09122810, b) B242C10062810, c) B242C10122810, d) B242C11062810, e) B242C11122

Medicrea International

DeRoyal KIT HEART B PACK, REF 89-9042.08

DeRoyal Industries Inc

HUNTLEIGH Disposable intraoperative Probe, 8Mhz (box), REF DIPP10, containing 10 individual Disposable Intraoperative Pr

Huntleigh Healthcare Ltd.

AD-TECH Spencer Probe Depth Electrode, REF SD06R-AP58X-000 6-Contact 1.12mm (A style) Depth Electrode

Ad-Tech Medical Instrument Corporation

EMPOWR VVC KNEE TIBIAL INSERT, SIZE 6, 22MM, REF: 346-22-706; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 7, 22MM, REF: 346-22-7

Encore Medical, LP

Reusable distal attachments Models: MH-462, MH-463, MH-464, MH-465, MH-466, MH-483, MH-587, MH-588(US), MH-589, MH-590

Aomori Olympus Co., Ltd.

Soltive Premium Super Pulsed Laser System (TFL-PLS) & Pro Super Pulsed Laser System (TFL-SLS). Intended for incision, ex

Olympus Corporation of the Americas

1ml of DTT in liquid phase, in PET tube with capture cap, in bulk

Copan Italia

Catalog No. 8888160341; Umbilical Vessel Catheter 5 French single lumen

Cardinal Health 200, LLC

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

MEDLINE INDUSTRIES, LP - Northfield

LEFT LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number: 6637-0-231

Howmedica Osteonics Corp.

ECONO STERILE medical procedure kits labeled as: ECONO STERILE BLAKE GALLSTONE FCP CVD 8"CS25, Model Number 96-4921A

Sklar Instruments

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

MEDLINE INDUSTRIES, LP - Northfield

Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;

Covidien, LP

Proclaim" XR 7 Implantable Pulse Generator REF 3662 (previously known as Proclaim" 7 Elite IPG) Product Description:

Abbott Medical

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4483; use in Peritoneal Dialysis

Baxter Healthcare Corporation

Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38

Exactech, Inc.

Allergy & Food Intolerance Test

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Cardiohelp-i Transport Guard with Transport Guard (701072525): is a blood oxygenation and carbon dioxide removal syst

Maquet Medical Systems USA

Medline medical procedure kits labeled as follows: a) BASIC NEURO, REF DYNJ909171A; b) NEURO, REF DYNJ905510D; c)

MEDLINE INDUSTRIES, LP - Northfield

LIFEPAK 15, REF: 99577-000055, Part Number V15-2-000061

Physio-Control, Inc.

Cardiovascular Procedure Kit catalog # 76645 & 73806

Terumo Cardiovascular Systems Corp

Compress Device Short Anchor Plug, 10 MM-Correction of revision of unsuccessful osteotomy, arthrodesis, or previous join

Biomet, Inc.

CPT Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis, used in Hip Arthroplasty; Item Numbers 00811400000 00

Zimmer, Inc.

BD Alaris Pump Infusion Buerette Set Smallbore Tubing Smartsite Port (Burette) 3 SmartSite Y-Sites, REF: 2441-0006

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