ROi CPS Recalls Custom Procedure Packs Containing Recalled Clearlink Devices
ROi CPS LLC is recalling 412 custom procedure packs containing Clearlink Continu-Flo devices that were previously recalled by Baxter Healthcare Corporation.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves medical devices (Class II) that were previously recalled by the manufacturer, indicating a known risk of harm, but the source text does not report specific injuries or deaths.
Plain-English summary
ROi CPS LLC is recalling 412 custom procedure packs that contain Clearlink Continu-Flo devices. These devices were previously recalled by Baxter Healthcare Corporation. The affected packs are labeled with specific item numbers and lot numbers, including those for vaginal delivery, central line, and PICC procedures.
The recall is limited to the United States, specifically affecting the states of Arkansas, Oklahoma, Missouri, and Kansas. The products are custom procedural trays containing surgical instruments and accessories intended for use during surgical procedures.
Healthcare facilities and consumers should stop using these specific packs and contact ROi CPS LLC for further instructions or a return.
The recalled product
- 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 - M
- Manufacturer
- ROi CPS LLC
- Hazard
- Affected units
- 412
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- a) Item Number 830015012 Lot Numbers: 72700L
- 74508L b) Item Number: 830027 Lot Numbers: 72702C
- 74403B e) Item Number
- 880189011 Lot Numbers: 73173K
Distribution
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