Recall Z-0918-2020 ยท LRO General Surgery Tray
ROi CPS LLC
Custom procedure packs, containing Clearlink Continu-Flo, labeled as follows: a) regard LD00200L-VAG DELIVERY MOTHER - JOPLIN, Item Number 830015012 b) regard GS00310C - Max Barrier Central Line Trpl Lumen 16cm, Sulfa-coated catheter, Item Number: 830027 c) regard GS00309B - Max Barrier Central Line Dual Lumen 16cm, Sulfa-coated catheter, Item Number: 830026 d) regard GS00307B - Max Barrier Centra
| Date | Jan 3, 2020 |
| Status | Terminated |
| Reason | ROi CPS, LLC manufactured custom procedure packs using Clearlink Continu-Flo devices which were subsequently recalled by Baxter Healthcare Corporation. |
| Root cause | Other |
| Action | The firm notified its direct consignee by letter disseminated by email on 01/03/2020. The direct consignee in turn notified the end user by email. The notice requested that the user follow the IFU and ensure a full and secure friction fit between the Continu-Flo Luer and the ONE-LINK connector. |
| Quantity | 412 packs |
| Distribution | US: AR, OK, MO, KS |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.