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Potential contamination with Listeria monocytogenes
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the current labeling for this electronic product may be missing a required Certification Statement under 21 CFR Subchapter J (Radiological Health Regulations). Specifically, the following statement may have been omitted: Certification Statement: This electronic product complies with all applicable performance standards prescribed under 21 CFR Subchapter J, as enforced by the U.S. Food and Drug Administration at the date of manufacturing.
Reports of vascular graft delamination, which may lead to reduced access flow; cannulation difficulties; bleeding or bruising; and harms related to reintervention procedures, so Instructions for Use will be updated to modify existing warning to 1) further clarify techniques that may contribute to the risk of delamination, 2) Addition of delamination to device-related adverse event section.
Shell egg product potentially contaminated with salmonella.
Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.
Presence of a foreign substance.
Cross Contamination with Other Products.
One lot manufactured with an invalid sterilization cycle.
Video fluoroscopy table may contain inadequate weld on backrest bracket resulting in backrest dropping.
If a user incorrectly places the Acquisition Module into the Acquisition Module Holder, it can result in excessive bending and wear of the Acquisition Trunk Cable. This is visible as a damaged sheath or exposed wires. If a damaged Acquisition Trunk Cable is not recognized and removed from service, the cable can overheat with continued use.
Subpotent/Super-potent Product: Testing of the SPF 50 sunscreen revealed inconsistency in SPF results ranging from SPF 4, 10, 21, 26, 33, 60, 61, and 64.