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Medical Devices Recalls

Medical equipment, implants, and diagnostic devices

38,779 Total Recalls

Ora Plug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes.

Integra LifeSciences

Class I - Dangerous

Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

Mar 28, 2013 Infusion Pumps Nationwide View Details →

HeliTape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes.

Integra LifeSciences

Class I - Dangerous

Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

Mar 28, 2013 Infusion Pumps Nationwide View Details →

Zilver¿ PTX¿ Drug-Eluting Peripheral Stent - 6 mm X 80mm; 125 cm, Rx, Sterile Product Usage: The Zilver PTX Drug -Eluting Peripheral Stent is a self expanding, small metal, mesh tube (stent) with the outer surface coated with the drug Paclitaxel that can be Implanted in an artery in the thigh (femoropopliteal artery). The Paclitaxel coating helps Preven the artery from narrowing again (restenosis). The Zilver; PTX stent acts as a scaffold to: Hold open a narrowed artery in the thigh (femoropopliteal artery) caused by PAD . improve blood flow to the extremity.

Cook

Class I - Dangerous

Cook Medical has received a small number of complaints related to the delivery system for the Zilver PTX Drug-Eluting Peripheral Stent involving fractures of the delivery system inner catheter after stent deployment, and separation of the inner catheter tip section (13 complaints with an occurrence rate of 0.043%) Two adverse events, including one death, occurred in cases where a tip separation

Apr 18, 2013 Implants & Prosthetics Nationwide View Details →

ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR, Soft, disposable contact lenses. The Vistakon (galyfilcon A) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or non-aphakic persons with non-diseased eyes who may have 1.00D of astigmatism or less.

Johnson & Johnson Vision Care

Class I - Dangerous

Limited number of individual contact lens packages may not have been completely sealed.

Dec 21, 2012 Infusion Pumps Nationwide View Details →

Electrode, cutting, 24FR (27050G/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).

Karl Storz Endoscopy America

Class I - Dangerous

Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.

Jun 1, 2009 Infusion Pumps Nationwide View Details →

BioMend¿ Extend" Absorbable Collagen Membrane BioMend¿ Extend" Absorbable Collagen Membrane is an absorbable, implantable material that is indicated for guided tissue regeneration procedures in periodontal defects to enhance regeneration of the periodontal apparatus.

Integra LifeSciences

Class I - Dangerous

Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

Mar 28, 2013 Implants & Prosthetics Nationwide View Details →

Electrode, Roller, Vaporization, 24FR (27050RK/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).

Karl Storz Endoscopy America

Class I - Dangerous

Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.

Jun 1, 2009 Infusion Pumps Nationwide View Details →

Helitene Absorbable Collagen Hemostatic Sponge Helitene is indicated in surgical procedures (other than ophthalmological and urological surgery) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.

Integra LifeSciences

Class I - Dangerous

Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

Mar 28, 2013 Surgical Instruments Nationwide View Details →

PROFILE-V MEDTOXScan Drugs of Abuse Test System. For the rapid, qualitative detection of drugs of abuse in human urine,

Medtox Diagnostics

Class I - Dangerous

Review of validation information and customer complaints which indicated preliminary screen positive results for cocaine that were not positive on confirmatory testing.

Apr 5, 2013 Diagnostic Equipment Nationwide View Details →

BBL(tm) CDC Anaerobe 5% Sheep Blood Agar. Used for culturing microorganisms.

Becton Dickinson &

Class I - Dangerous

Microbiological media may be contaminated with bacteria.

Mar 11, 2013 Other Medical Devices Nationwide View Details →

BBL(tm) Trypticase (tm) Soy Agar with 5% Sheep Blood. Used for culturing microorganisms.

Becton Dickinson &

Class I - Dangerous

Microbiological media may be contaminated with bacteria.

Mar 11, 2013 Other Medical Devices Nationwide View Details →

1-DAY ACUVUE MOIST Brand Contact Lenses, soft disposable contact lenses. The Vistakon (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Tinted (Visibility and/or Cosmetically), with UV Blocker for Daily Disposable Wear (spherical) is indicated for daily wear to enhance or alter the apparent color of the eye and/or for the correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with not diseased eyes who may have 1.00D or less of astigmatism.

Johnson & Johnson Vision Care

Class I - Dangerous

Limited number of individual contact lens packages may not have been completely sealed.

Dec 21, 2012 Infusion Pumps Nationwide View Details →

Electrode, Roller Ball, 24FR (27050NK/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).

Karl Storz Endoscopy America

Class I - Dangerous

Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.

Jun 1, 2009 Infusion Pumps Nationwide View Details →

OraMem Absorbable Collagen Membrane OraMem¿ Absorbable Collagen Membrane is an absorbable, implantable material that is indicated for guided tissue regeneration procedures in periodontal defects to enhance regeneration of the periodontal apparatus.

Integra LifeSciences

Class I - Dangerous

Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

Mar 28, 2013 Implants & Prosthetics Nationwide View Details →

Summit Medical, BL-2006, Myringotomy Lance (Juvenile) Blade, Sterile P, Summit Medical, Inc., 815 Northwest Parkway, Suite 100, St. Paul, MN 55121 Use to make an incision in the tympanic membrane.

Summit Medical

Class I - Dangerous

Summit Medical has initiated a recall of Myringotomy Lance Blade (Juvenile) because the box contains the wrong blade. The box contains Myringotomy Spear Blade (Juvenile).

Mar 27, 2013 Other Medical Devices View Details →

DuraGen XS Dural Regeneration Matrix DuraGen XS Dural Regenerative Matrix is an absorbable implant for repair of dural defects. DuraGen XS is an easy to handle, soft, white, pliable, non-friable, porous collagen matrix. DuraGen XS is supplied sterile, non-pyrogenic, for single use in double peel packages in a variety of sizes.

Integra LifeSciences

Class I - Dangerous

Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

Mar 28, 2013 Implants & Prosthetics Nationwide View Details →

QIAGEN artus CMV RG PCR ASR (24) (Catalog number 4503223) Product Usage: The artus CMV RG PCR ASR is designed to detect and to quantify nucleic acid specific to human cytomegalovirus (CMV) using real-time PCR technology (PCR) in the Rotor-Gene 2000/3000 (RG).

QIAGEN Gaithersburg

Class I - Dangerous

CMV RG PCR kits may contain a mixture of incorrect vials among the correct vials.

Jan 30, 2013 Other Medical Devices Nationwide View Details →

Proplege Coronary Sinus Catheter model PR9, 11 French Introducer, kitted with PR9. Product Usage: The catheter introducer sheath kit provides access to the central venous circulation to facilitate catheter and guidewire insertion. The Proplege coronary sinus catheter provides retrograde cardioplegia during cardiopulmonary by-pass surgery.

Edwards Lifesciences

Class I - Dangerous

Edwards Lifesciences is recalling certain Proplege Coronary Sinus Catheter, model PR9 due to confirmed reports of blood leakage through the hemostasis valve in the introducer that is kitted with the catheter.

Jan 25, 2013 Surgical Instruments Nationwide View Details →

NeuraWrap Nerve Protector NeuraWrap Nerve Protector is indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue.

Integra LifeSciences

Class I - Dangerous

Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

Mar 28, 2013 Other Medical Devices Nationwide View Details →

BioMend Absorbable Collagen Membrane BioMend¿ Absorbable Collagen Membrane is an absorbable, implantable material that is indicated for guided tissue regeneration procedures in periodontal defects to enhance regeneration of the periodontal apparatus.

Integra LifeSciences

Class I - Dangerous

Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

Mar 28, 2013 Implants & Prosthetics Nationwide View Details →