FDA Device recall Z-0837-2022
Regard Custom Procedure Kits containing BD Luer Lok Access Devices
- FDA Device
- Class III
- terminated
- Published 2022-04-06
On 2022-04-06 the FDA classified a Class III recall of Regard Custom Procedure Kits containing BD Luer Lok Access Devices by Roi Cps, citing recalled devices were packaged in convenience kits.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0837-2022 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2022-02-24 |
| Published | 2022-04-06 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Roi Cps |
| Distribution | US |
Product
Regard Custom Procedure Kits containing BD Luer Lok Access Devices
Reason
Recalled devices were packaged in convenience kits.
Identifiers
| code_info | IV START LABOR BIRTH convenience kits: 1) Item No. 830110, Lots 89222 and 87572 (exp. MAR/12/2022 2) Item No. 830110002…IV START LABOR BIRTH convenience kits: 1) Item No. 830110, Lots 89222 and 87572 (exp. MAR/12/2022 2) Item No. 830110002, Lots 91226, 90641, and 90446 (exp. MAY/12/2022) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0837-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.