FDAJanuary 3, 2020device
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 L...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
ROi CPS, LLC manufactured custom procedure packs using Clearlink Continu-Flo devices which were subsequently recalled by Baxter Healthcare Corporation.
What to do
FDA enforcement status: Terminated
Brands named
roi cpsroi
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAregard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to be used in Labor and Delivery.2024-12-26
- FDAregard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 8002230092024-07-24
- FDARegard Kit containing the Microtek decanter2024-06-17
- FDAregard Operative LAP, Item Number 800943001; surgical convenience kit2023-12-18
- FDARegard Dressing change kit, Item Number 8000260062023-11-20
- FDARegard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit2023-09-21
- FDAGS0008 2Y - Burn Pack - STL, Item Number 8800820252023-09-11
- FDASterile surgical convenience kits: 1. regard Item Number: 880473001, OR01105A - Total Shoulder/Hip; 2. regard Item Number: 880426004, OR01033D - Total Hip; 3. regard Item Number: 880427003, OR01034C - Total Knee; 4. regard Item Number: 880474001, OR01106A - Knee Arthroscopy; 5. regard Item Number...2023-03-22
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