Recall Z-0837-2022
ROi CPS LLC · initiated February 24, 2022
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
Regard Custom Procedure Kits containing BD Luer Lok Access Devices
Codes / lots: 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)
Reason for recall
Recalled devices were packaged in convenience kits.
FDA-determined cause: Material/Component Contamination
Action taken
A customer letter dated February 24, 2022 was issued to the impacted consignee. The letter instructs the consignee to perform a microscopy to confirm an elevated RBC count in a urine sample as the impacted component may shed contaminant particles that are identified as RBCs when used in conjunction with the Sysmex UF-1000i or UX-2000 analyzers. A reply form should be completed and returned to ROi confirming receipt and understanding of the notification. End users should retain a copy of the BD notice and post near the analyzer as a visual reminder of the potential issue with the BD product.
Details
- Recall number
- Z-0837-2022
- Initiated
- February 24, 2022
- Terminated
- April 25, 2022
- Product code
- LRS – I.V. Start Kit
- Quantity
- 1750 kits
- Distribution
- US Nationwide distribution in the state of Missouri.
- Recalling firm
- ROi CPS LLC, Republic, MO