PlainRecalls
FDA Devices Moderate Class II Ongoing

CENTURION MEDICAL PRODUCTS, LP Centurion CATH KIT, FML W/LUBE 8FR (50/CS) CNTURN Catalog # CKF105L

Reported: August 31, 2022 Initiated: May 25, 2022 #Z-1630-2022

Product Description

CENTURION MEDICAL PRODUCTS, LP Centurion CATH KIT, FML W/LUBE 8FR (50/CS) CNTURN Catalog # CKF105L

Reason for Recall

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.

Details

Distribution
US Nationwide
Location
Richmond, VA

Frequently Asked Questions

What product was recalled?
CENTURION MEDICAL PRODUCTS, LP Centurion CATH KIT, FML W/LUBE 8FR (50/CS) CNTURN Catalog # CKF105L. Recalled by Mckesson Medical-Surgical Inc. Corporate Office.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on August 31, 2022. Severity: Moderate. Recall number: Z-1630-2022.