FDA Device recall Z-0264-2019
CHS Custom Convenience Kit-SURGICAL GOWN, LARGE SET IN SLEEVES Product Number:1231-050L
- FDA Device
- Class II
- terminated
- Published 2018-10-31
On 2018-10-31 the FDA classified a Class II recall of CHS Custom Convenience Kit-SURGICAL GOWN, LARGE SET IN SLEEVES Product Number:1231-050L by Custom Healthcare Systems, citing convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0264-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-08-13 |
| Published | 2018-10-31 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Custom Healthcare Systems |
| Distribution | CT, GA, IL, KY, MD, NC, OK, SC, VA |
Product
CHS Custom Convenience Kit-SURGICAL GOWN, LARGE SET IN SLEEVES Product Number:1231-050L
Reason
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
Identifiers
| code_info | Lot numbers: W72018, W71218 Exp Date:7/1/2021 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0264-2019%22
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