Recall Z-1301-2020— Cardinal Health 200, LLC
Class II · Terminated
Class II FDA medical device recall by Cardinal Health 200, LLC, initiated 2020-01-31, terminated 2023-02-01. FDA's recall record names no specific 510(k) clearance for this event. Product: Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Reason: The kits contained recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that the surgical gowns are sterile. An inadequately sterilized surgical gown could compromise a sterile field and increase the risk of a surgical site infection..
- Recalling firm
- Cardinal Health 200, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-01-31
- Terminated
- 2023-02-01
- Firm location
- Waukegan, IL, United States
Product description
Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020
Reason for recall
The kits contained recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that the surgical gowns are sterile. An inadequately sterilized surgical gown could compromise a sterile field and increase the risk of a surgical site infection.
Data sourced from openFDA. This site is unofficial and independent of the FDA.