FDA Device recall Z-0918-2020
Custom procedure packs, containing Clearlink Continu-Flo, labeled as follows: a) regard LD00200L-VAG DELIVERY MOTHER - JOPLIN, Item Number…
- FDA Device
- Class II
- terminated
- Published 2020-02-05
On 2020-02-05 the FDA classified a Class II recall of Custom procedure packs, containing Clearlink Continu-Flo, labeled as follows: a) regard LD00200L-VAG DELIVERY MOTHER - JOPLIN, Item Number… by Roi Cps, citing ROi CPS, LLC manufactured custom procedure packs using Clearlink Continu-Flo devices which were subsequently recalled by Baxter Healthcare Corporation.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0918-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-01-03 |
| Published | 2020-02-05 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Roi Cps |
| Distribution | AR, KS, MO, OK |
Product
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 Central Line Trpl Lumen 20cm, Sulfa-coated catheter, Item Number: 830024 e) regard AN00211K - PICC PACK - WASHINGTON, Item Number, 880189011 f) regard GS00311B - Max Barrier Central Line Quad Lumen 20cm, Sulfa-coated catheter, Item Number: 830028 g) regard LD00866B-VAG DELIVERY MOTHER - LEBANON, Item Number 830084 h) regard LD00199NL-C SECTION MOTHER - JOPLIN, Item Number 830014 i) regard GS0348D - CVC TRIPLE LUMEN 20CM NON SULFA - , Item Number 830034 Product Usage: These custom procedural trays contain surgical instruments and accessories intended for use during a surgical procedure.
Reason
ROi CPS, LLC manufactured custom procedure packs using Clearlink Continu-Flo devices which were subsequently recalled by Baxter Healthcare Corporation.
Identifiers
| code_info | a) Item Number 830015012 Lot Numbers: 72700L, 74508L b) Item Number: 830027 Lot Numbers: 72702C, 74406C c) It…a) Item Number 830015012 Lot Numbers: 72700L, 74508L b) Item Number: 830027 Lot Numbers: 72702C, 74406C c) Item Number: 830026 Lot Numbers: 72897B d) Item Number: 830024 Lot Numbers: 73325B, 74403B e) Item Number, 880189011 Lot Numbers: 73173K, 74855K f) Item Number: 830028 Lot Numbers: 73666B g) Item Number 830084 Lot Numbers: 74354B h) Item Number 830014 Lot Numbers: 74373N i) Item Number 830034 Lot Numbers: 68336D |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0918-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.