PlainRecalls
FDA Devices Low Class III Ongoing

3M SYSTAGENIX/KCI KerraCel Ag DRESSING, WOUND KERRACEL AG 4X5 (10/CT 10CT/CS) Catalog #CWL1158

Reported: October 5, 2022 Initiated: May 25, 2022 #Z-1807-2022

Product Description

3M SYSTAGENIX/KCI KerraCel Ag DRESSING, WOUND KERRACEL AG 4X5 (10/CT 10CT/CS) Catalog #CWL1158

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. This device with this specific storage temperature deviation is not likely to cause adverse health consequences.

Details

Units Affected
16.9 ct
Distribution
US Nationwide distribution.
Location
Richmond, VA

Frequently Asked Questions

What product was recalled?
3M SYSTAGENIX/KCI KerraCel Ag DRESSING, WOUND KERRACEL AG 4X5 (10/CT 10CT/CS) Catalog #CWL1158. Recalled by Mckesson Medical-Surgical Inc. Corporate Office. Units affected: 16.9 ct.
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. This device with this specific storage temperature deviation is not likely to cause adverse health consequences.
Which agency issued this recall?
This recall was issued by the FDA Devices on October 5, 2022. Severity: Low. Recall number: Z-1807-2022.