Medical equipment, implants, and diagnostic devices
Covidien
On March 26, 2013 Covidien received a recall notice from one of their suppliers CareFusion. CareFusion is recalling a variety of OTC drug products including the 10% Povidone Iodine SEPP Applicator which is utilized in specific convenience kits.
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.
Karl Storz Endoscopy America
Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.
CMV RG PCR kits may contain a mixture of incorrect vials among the correct vials.
Karl Storz Endoscopy America
Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.
LifeLiner Stick and Cut Resistant Gloves are being recalled because cases and individual glove packages were mispackaged, with right handed, large sized glove packaging containing left handed, large sized gloves.
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.
American Medical Systems, Inc. is initiating a recall on two components of the AMS 800Âŋ Urinary Control System, Control Pump & Pressure-Regulating Balloon. These products were released despite not meeting all final product release criteria.
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.
While performing a fluoroscopic examination on the GE Innova systems, there is a potential of nonrecoverable loss of imaging modes with no advance warning, due to a relay failure in the power distribution box (PDB). Although no injuries have been reported due to this issue to date, there is risk of complications during the procedure as a result of imaging functionality loss.
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
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.
The Liquichek" ToRCH Plus IgM Control - Positive, contains detectable levels of HCV RNA which originated from the non-specific human IgM component used in the mouse monoclonal antibody conjugation process for this product.
American Medical Systems, Inc. is initiating a recall on two components of the AMS 800Âŋ Urinary Control System, Control Pump & Pressure-Regulating Balloon. These products were released despite not meeting all final product release criteria.
The firm initiated this recall because complaints from customers reported that the recovery compared to assigned assay values is significantly below specification. This results in the instrument not passing controls and the customer not being able to run patient samples.
On March 26, 2013 Covidien received a recall notice from one of their suppliers CareFusion. CareFusion is recalling a variety of OTC drug products including the 10% Povidone Iodine SEPP Applicator which is utilized in specific convenience kits.
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.
Karl Storz Endoscopy America
Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.
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.
The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123ÂŋC , instead of the correct 132-133ÂŋC.