Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1443-2024 — 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

U.S. FDA — Device Enforcement · United States · 2024-02-23 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1443-2024
Date of alert
2024-02-23
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
MEDLINE INDUSTRIES, LP - Northfield
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00653160350944
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.