Presource Procedure Packs containing AAMI Level 3 surgical gowns — Class II medical device recall Z-1235-2020
Terminated recall by Cardinal Health 200, LLC, reported 2020-02-26, distributed nationwide. The kits contained recalled surgical gowns. The gowns were manufactured at locations that did not maintain pro
| Recall number | Z-1235-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardinal Health 200, LLC, Waukegan, IL, United States |
| Recall initiated | 2020-01-31 |
| Classified | 2020-02-14 |
| Reported by FDA | 2020-02-26 |
| Terminated | 2023-01-19 |
| Distributed | Nationwide (US) |
| Reason classes | sterility |
| Lot numbers | 100161, 101046, 101181, 101195, 101995, 102276, 102874, 102985, 103222, 104219, 105013, 106359, 106498, 106675, 107157, 107280, 107493, 107723, 107863, 107901, 108177, 108209, 108371, 108475, 108690, 109011, 109057, 109086, 109249, 109264, 109816, 109883, 110062, 110159, 110190, 110658, 110769, 110964, 110991, 111175 and 460 more |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1235-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.