Medical equipment, implants, and diagnostic devices
The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the edge of the sterile package for the following products: List No. 04693-01, Latex Free Extension Set; List No. 06543-01, Nonvented Y-Set for Transurethral Resection; List No. 06544-01 Cystoscopy / Irrigation Set; List No. 06599-01, Large Bore Y-Irrigation Set (Latex-Free); and, List No. 15239-01, 4-Lea
The Infant Nasal CPAP Prong has the potential to detach from the Nasal Tubing and therapy is likely to be interrupted.
SCM True Air Technologies
The firm is recalling the products due to lack of design controls, lack of a Device Master Record, and failure to approve specific vendors.
The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the edge of the sterile package for the following products: List No. 04693-01, Latex Free Extension Set; List No. 06543-01, Nonvented Y-Set for Transurethral Resection; List No. 06544-01 Cystoscopy / Irrigation Set; List No. 06599-01, Large Bore Y-Irrigation Set (Latex-Free); and, List No. 15239-01, 4-Lea
Siemens Medical Solutions USA
Table may lose calibration during patient treatment, which may cause the possibility of mistreatment.
SCM True Air Technologies
The firm is recalling the products due to lack of design controls, lack of a Device Master Record, and failure to approve specific vendors.
Siemens Medical Solutions USA
There is a potential and possible hazard to the user when using the MAMMOMAT Inspiration PC monitor at the control desk, in that the holder of the PC monitor can break causing an unstable monitor to fall causing possible serious injury.
SCM True Air Technologies
The firm is recalling the products due to lack of design controls, lack of a Device Master Record, and failure to approve specific vendors.
Maquet Datascope Corp - Cardiac Assist Division
Potential mechanical failure of the fan assembly associated with the power supply. A fan assembly failure could result in the power supply overheating and cause the IABP to shut down without warning.
Fresenius Medical Care Holdings
Naturalyte Liquid Bicarbonate maybe contaminated
A complaint reported that the archiving method at one customer site was changed from implicit to explicit, and the cleanup procedure enabled by the explicit archiving method may have deleted data from archive itself.
This lot did not go through the correct sterilization procedures. This product may potentially be non-sterile.
During a transfer of products from a recently shutdown facility, the firm discovered raw material labeled as latex free actually contained latex.
During a transfer of products from a recently shutdown facility, the firm discovered raw material labeled as latex free actually contained latex.
Fresenius Medical Care Holdings
2008-Series Hemodialysis Machines with Revision K Actuator Test Boards may fail to detect a disconnected Ultrafiltration (UF) Pump
Fresenius Medical Care Holdings
2008-Series Hemodialysis Machines with Revision K Actuator Test Boards may fail to detect a disconnected Ultrafiltration (UF) Pump
During a transfer of products from a recently shutdown facility, the firm discovered raw material labeled as latex free actually contained latex.
Patients and caregivers are instructed that if a battery does not provide two hours of support or behaves unusually, that battery should no longer be used and should be replaced.
William Domb is recalling the Enaly 1000 BT-12 Ozone Generator because it is not approved or cleared by the FDA for medical use.
Leak issues were discovered through accelerated age testing.