Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.
Reported: February 26, 2020 Initiated: January 31, 2020 #Z-1235-2020
Product Description
Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.
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.
Details
- Recalling Firm
- Cardinal Health 200, LLC
- Units Affected
- 2,161,526 units (113, 711 additional units as of 2/25/20)
- Distribution
- US Nationwide.
- Location
- Waukegan, IL
Frequently Asked Questions
What product was recalled? ▼
Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.. Recalled by Cardinal Health 200, LLC. Units affected: 2,161,526 units (113, 711 additional units as of 2/25/20).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 26, 2020. Severity: Moderate. Recall number: Z-1235-2020.
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