Regard CV PK recall
Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit
Why was Regard CV PK recalled?
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 should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
a) UDI/DI 10194717111702, Lot Numbers: 94114, 95436; b) UDI/DI 10194717117049, Lot Numbers: 96442
- Product
- Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit
- Recalling firm
- ROi CPS LLC
- Quantity
- 134 units
- Distribution
- MO
- Recall date
- November 22, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)