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GMP deficiencies
Design has insufficient articulating distance between the two component plates to prevent disassociation in vivo.
cloudy appearance or precipitate
Non-invasive blood pressure readings on central station may not match bedside monitor due to software anomaly.
Lens may be labeled with incorrect diopter size.
The 3M Attest 1292 Rapid Readout Biological Indicators for steam sterilization may contain ampoules which may result in a false negative readout at 3 hours.
Instrument malfunction. Electrical short circuit may occur resulting in damage or a fire hazard.
The product is labeled as sterile product but had not been sterilized.
The closure flap of the recalled sharps containers have two tabs that fit into slots on the cover for final closure and locking but some of the covers have one of the tabs that will not fit into the designated slot because the slot is occluded with plastic.
A retrospective review of donor files conducted by CryoLife revealed an expired solution had been used during processing of the associated tissues.
Incorrect Test Results-product may show a higher than expected platelet background count when used on the CELL-DYN 4000 System and report patient results that are unacceptable (out-of-range).
The locking ring was not included and the shoulder implanted without the locking ring.
Injector mold design/manufacture and wear caused material flash to develop preventing assembly of the device prior to use.
The actuator valve is defective, which may allow the valve to remain open after use and continue to spray until the can is empty.