Medical Device Recall: Centurion manual surgical kits labeled as: a) STERILE ALLIS TISS FCP 10", Product Code I68905; b) VAGINAL REPAIR KIT, Product Code MNS11505; c) PTCA ADD-ON KIT, Product Code MNS11545; d) INSTR
MEDLINE INDUSTRIES, LP - Northfield · February 23, 2024
Reason for Recall
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
Product Description
Centurion manual surgical kits labeled as: a) STERILE ALLIS TISS FCP 10", Product Code I68905; b) VAGINAL REPAIR KIT, Product Code MNS11505; c) PTCA ADD-ON KIT, Product Code MNS11545; d) INSTRUMENT SET, Product Code SUT21355
Distribution
Worldwide distribution - US Nationwide and the countries of Panama, Canada.
States Affected
NATIONWIDE
Quantity Affected
1335 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1443-2024
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.