Z-0837-2022 Class III Terminated
FDA device recall Z-0837-2022 was initiated by ROi CPS LLC on Feb 24, 2022 and is designated Class III. Reason for recall: Recalled devices were packaged in convenience kits. The recall status is terminated (terminated Apr 25, 2022). Affected quantity: 1750 kits.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 6, 2022
- Initiation Date
- Feb 24, 2022
- Termination Date
- Apr 25, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1750 kits
Product Description
Regard Custom Procedure Kits containing BD Luer Lok Access Devices
Reason for Recall
Recalled devices were packaged in convenience kits.
Distribution Pattern
US Nationwide distribution in the state of Missouri.
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)
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0837-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026