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Patient support table floor plate may be incorrectly installed.
Products have a lack of sterility assurance.
Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump
Size 5 Tibial Tray from Lot 508287 was packaged in a Size 4 box from Lot 540287. It was confirmed that Lot 540287 and Lot 508287 were swapped between the pouching and final pack.
System error messages may delay the ability to test patient samples and the need for frequent calibration due to results outside the expected range when testing controls.
A possible sterility issue (e.g. a breach in sterile packaging) was detected in Coloplast's facility on some ureteral dilator products. This issue on the ureteral dilator packaging has been identified during testing in our facility.
Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Hip Distraction System, Traction Boot II, due to the boots being assembled incorrectly. The locking ridge on the front face of the boot key socket is facing upwards, which prevents the socket mechanism on the traction boot from attaching properly to the spar of the traction system. This will cause the boot to detach from the traction system.
Due to a misaligned calibration of the wired controller that may result in unintended motion of the scope.
Degraded and unusable upon removal from the foil pouch due to exposed environmental conditions during transit and storage, compromising sterility
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters.
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
Upon initial activation of the seal function, the POWERSEAL non-conformance results in an immediate Incomplete Seal Cycle tone with the accompanying message on the generator screen, and no energy would be delivered to the device resulting in delay in surgery.
Software has anomalies that have the potential to cause underdose, overdose, or delay in therapy which could lead to serious patient harm or death.
The blood cultures performed as part of the organ donation process were positive for Staphylococcus aureus.