Recall Z-0837-2022 ยท LRS I.V. Start Kit
ROi CPS LLC
Regard Custom Procedure Kits containing BD Luer Lok Access Devices
| Date | Feb 24, 2022 |
| Status | Terminated |
| Reason | Recalled devices were packaged in convenience kits. |
| Root cause | Material/Component Contamination |
| Action | 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. |
| Quantity | 1750 kits |
| Distribution | US Nationwide distribution in the state of Missouri. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K991088 | VACUTAINER BRAND MULTIPLE SAMPLE LUER ADAPTER, BLOOD COLLECTION SETS AND SAFETY-LOK BLOOD COLLECTION, SAFETY BLOOD COLLE Becton Dickinson Vacutainer Systems, May 28, 1999 |