🍔 Food 💊 Drugs 🏥 Medical Devices
PrepStain Tecan US-I. For use in the screening and detection of cervical cancer. Class II

Reason: PrepStain system rack setting was incorrectly entered on one PrepStain system during a routine preventive maintenance visit by a BD Field Service Representative.

Becton Dickinson & Co. 20130708 Terminated
Distributed: Worldwide Distribution-USA (nationwide) and Puerto Rico and the country of Canada.
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PrepStain AG. For use in the screening and detection of cervical cancer. Class II

Reason: PrepStain system rack setting was incorrectly entered on one PrepStain system during a routine preventive maintenance visit by a BD Field Service Representative.

Becton Dickinson & Co. 20130708 Terminated
Distributed: Worldwide Distribution-USA (nationwide) and Puerto Rico and the country of Canada.
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ACCU-CHECK FastClix Lancing Device. It is intended for use in conjunction with a blood glucose monitoring system. Class II

Reason: Internal Roche inspections have revealed that after the lancet is used for a finger stick, the needle may not fully retract back within the lancet drum or back into the cap. This allows the needle to protrude inside the cap or outside of the cap of the ACCU-CHEK FastClix lancing device.

Roche Diagnostics Operations, Inc. 20130819 Terminated
Distributed: Nationwide Distribution
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Axiom Artis systems. C-arm angiographic x-ray system x-ray, angiographic system. Class II

Reason: The firm became aware of a potential issue with Axiom Artis systems installed by a third party installer that may involve incorrect channel nuts being used.

Siemens Medical Solutions USA, Inc 20130426 Terminated
Distributed: US Distribution including the states of PA, NJ, DC, VA, MD and DE.
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SpineNet Bone Marrow Aspiration Needle Kit (which is the Ranfac Bone Marrow Aspiration Needle #74150-01M). Use to aspirate bone morrow. Class II

Reason: SpineNet was marketing this device to be used with SpineNet ACC device without FDA clearance or approval.

SpineNet 20130204 Terminated
Distributed: Distributed to one customer in Florida.
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Medtronic Custom Perfusion System with Trillium BioSurface (a polymer containing non-leaching heparin). Model Numbers: TL4X17R8, TL5D01R, TL5D02R, TL5D02R3, TL5D02R5, and TL6A65R7. Sterilized by Ethylene Oxide, Do no Reuse. Product Usage: Usage: This product is indicated for use in the extracorporeal circuit during cardiopulmonary surgery. Class II

Reason: Medtronic was notified that Edwards Lifesciences has initiated a product recall for the Rigid Suction Wand, model S099B. The Wands are included within certain Perfusion Tubing Packs that are manufactured and distributed by Medtronic.

Medtronic Inc. Cardiac Rhythm Disease Management 20130717 Terminated
Distributed: Worldwide Distribution - USA Nationwide CA, IL, LA, MI and the country of CANADA
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Medtronic Custom Perfusion System with Carmeda BioActive Surface. Model Numbers: CB1D82R12 and CB5N73R7. Sterilized by Ethylene Oxide, Do no Reuse. Product Usage: Usage: This product is indicated for use in the extracorporeal circuit during cardiopulmonary surgery. Class II

Reason: Medtronic was notified that Edwards Lifesciences has initiated a product recall for the Rigid Suction Wand, model S099B. The Wands are included within certain Perfusion Tubing Packs that are manufactured and distributed by Medtronic.

Medtronic Inc. Cardiac Rhythm Disease Management 20130717 Terminated
Distributed: Worldwide Distribution - USA Nationwide CA, IL, LA, MI and the country of CANADA
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Medtronic Custom Perfusion System. Model Numbers: 1D80R8, 1E34R1, 1F75R1, 1G49R2, 1G75R1, 1P07R8, 1P91R4, 5B15R11, and 5P51R9. Sterilized by Ethylene Oxide, Do no Reuse. Product Usage: This product is indicated for use in the extracorporeal circuit during cardiopulmonary surgery. Class II

Reason: Medtronic was notified that Edwards Lifesciences has initiated a product recall for the Rigid Suction Wand, model S099B. The Wands are included within certain Perfusion Tubing Packs that are manufactured and distributed by Medtronic.

Medtronic Inc. Cardiac Rhythm Disease Management 20130717 Terminated
Distributed: Worldwide Distribution - USA Nationwide CA, IL, LA, MI and the country of CANADA
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SpineNet Anterior Cervical Cage, Lordotic, Peek (originally submitted as Daytona Anterior Cervical Cage) Product Usage: Is indicated for use in skeletally mature patients with degenerative disc disease of the cervical spine with accompanying radicular symptoms at one disc level Class II

Reason: The recall decision has been made because because it has recently been determined that the instructions for use (IFU) had certain statements that should have been removed prior to initial product marketing.

SpineNet 20130205 Terminated
Distributed: USA Nationwide Distribution in the state of Florida
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ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM DISTAL MEDIAL HUMERAL LOCKING PLATE, SHORT RIGHT 11 HOLES 178 MM LENGTH STERILE RX ONLY Product Usage: Usage: The Periarticular Locking Plate System is indicated for temporary internal fixation and stabilization of osteotomies and fractures, including: Comminuted fractures, supracondylar fractures, intra-articular and extra-articular condylar fractures, fractures in osteopenic bone, nonunions, and malunions. Class II

Reason: Zimmer is initiating a lot specific voluntary recall of the Distal Medial Humeral Locking Plate, Short due to the incorrect information printed on the Chinese label. The original label indicates that implants are RIGHT sided, but the Chinese label indicates that the implants are LEFT sided.

Zimmer, Inc. 20130730 Terminated
Distributed: Internationally Distributed in China only.
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