Reason: Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond the safety shield which could compromise the integrity of the package and the sterility of the scalpel leading to injury.
Distributed: Worldwide Distribution: US (nationwide) including states of: AL, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MN, MS, NC, NE, NY, OK, PA, PR, RI, TN, TX and WI; and country of: Canada.Reason: Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond the safety shield which could compromise the integrity of the package and the sterility of the scalpel leading to injury.
Distributed: Worldwide Distribution: US (nationwide) including states of: AL, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MN, MS, NC, NE, NY, OK, PA, PR, RI, TN, TX and WI; and country of: Canada.Reason: The wheels on Tracer IV wheelchairs (Tracer IV 24" seat width, 450 lbs. weight capacity manual wheel chair) were warped and wobbled when rolled.
Distributed: US Distribution: Michigan only.Reason: Welch Allyn will update Propaq 802 Series Vital Signs Monitor, models are 802LTAN, 802LTON and 802LTR with software because the fault conditions relating to hardware or software failure or electrical noise caused by proximal defibrillation activity could, in rare instances, potentially interrupt device operations.
Distributed: Worldwide Distribution - USA (nationwide) and Internationally to United Arab Emirates, Argentina, Australia, Belgium, Brazil, Canada, Switzerland, Chile, China, Columbia, Costa Rica, Czech Republic, Germany, Denmark, Ecuador, Spain, France, United Kingdom, Greece, Hong Kong,Taiwan, Ireland, Italy, Japan, Korea, Republic of, Kuwait, Lithuania, Luxemborg, Mexico, Malaysia, Mozambique, Namibia, Netherlands, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Sierra Leone, El Salvador, Thailand, Turkey, Uganda, Vietnam, Kosovo, and South Africa.Reason: Anspach was contacted by a hospital to inform Anspach that a Blackmax motor had been used in a case where the patient was diagnosed with Creutzfeldt-Jacob Disease (CJD).
Distributed: US Distribution: Maryland only.Reason: Anspach was contacted by a hospital to inform Anspach that a Blackmax motor had been used in a case where the patient was diagnosed with Creutzfeldt-Jacob Disease (CJD).
Distributed: US Distribution: Maryland only.Reason: The Color Cuff¿ Sterile Disposable Tourniquet Cuffs with Quick-Connect Fitting may have an incorrect end-connector. A customer reported having received a luer connector instead of a quick connect fitting. An incorrect connector may lead to an inoperable system due to incompatibility with the Smart Pump.
Distributed: US Distribution: including states of: MI, OH, and TX.Reason: 2008 Series Hemodialysis Machines complaints of saline bags inappropriately filling during recirculation and setup
Distributed: Worldwide Distribution - USA (nationwide) and Internationally Mexico and Canada.Reason: Shipped femur guide contained a non-conformance which could possibly impact fit of the drill insert.
Distributed: US Distribution: MO only.Reason: As the result of a recent internal review of regulatory documents, we have determined that the 10 mm x 12 mm Webless C-Plus implants were incorrectly documented as meeting the requirement for labeling as a partial Vertebral Body Replacement Device (VBR). While the use of this device as a partial VBR is unlikely due to the size of the device, use of this device as a partial VBR could result in a s
Distributed: Nationwide Distribution - USA including FL, MO, NY, CA, MI,and IL.