Device product
Regard Custom Procedure Kits containing BD Luer Lok Access Devices
Z-0837-2022
Product summary
- Firm
- ROi CPS LLC
- Event
- Event 89710
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1750 kits
- Official record key
device-enforcement:Z-0837-2022
Official wording
Reason: Recalled devices were packaged in convenience kits.
Code information: 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)
Distribution pattern: US Nationwide distribution in the state of Missouri.
Derived failure modes
-
Unknown
Recalled devices were packaged in convenience kits.