CHS Custom Convenience Kit-SURGICAL GOWN — Class II medical device recall Z-0264-2019
Terminated recall by Custom Healthcare Systems, Inc., reported 2018-10-31, distributed in CT, GA, IL, KY, MD, NC, OK, SC…. Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product st
| Recall number | Z-0264-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Custom Healthcare Systems, Inc., Richmond, VA, United States |
| Recall initiated | 2018-08-13 |
| Classified | 2018-10-25 |
| Reported by FDA | 2018-10-31 |
| Terminated | 2022-08-01 |
| Distributed | CT, GA, IL, KY, MD, NC, OK, SC, VA |
| Quantity | 7,200 units |
| Reason classes | sterility |
| Lot numbers | W71218, W72018 |
| Expiration dates | 2021-07-01 |
Product
CHS Custom Convenience Kit-SURGICAL GOWN, LARGE SET IN SLEEVES Product Number:1231-050L
Reason for recall
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
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-0264-2019. 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.