Official recall record
Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2023-09-21
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 10194717111702
- Brand on record
- ROi CPS LLC
- Product category
- Medical Device
What the authority reported
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
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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