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

CENTURION MEDICAL PRODUCTS, LP Centurion CATH KIT, FML W/LUBE 8FR (50/CS) CNTURN Catalog # CKF105L — recall Z-1630-2022

U.S. FDA — Device Enforcement · United States · 2022-05-25 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1630-2022
Date of alert
2022-05-25
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Mckesson Medical-Surgical Inc. Corporate Office
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00653160044300
Reported risk: Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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.