FDASeptember 21, 2023device
Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Specific Regard kits contain the Gentige Chest Drain Products being recalled by Gentige. The Instructions for Use (IFU) for the chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube connections with single collection chamber chest drains.
What to do
FDA enforcement status: Ongoing
Brands named
roi cpsroi
UPCs
1019471711170210194717117049
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
- 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
- FDASterile surgical convenience kits: 1. regard Item Number: 880405003, GS01011C - General Laparoscopy; 2. regard Item Number: 880424004, GS01031D - Thoracic.2023-03-22
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