Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit
Reported: November 22, 2023 Initiated: September 21, 2023 #Z-0315-2024
Product Description
Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit
Reason for Recall
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.
Details
- Recalling Firm
- ROi CPS LLC
- Units Affected
- 134 units
- Distribution
- MO
- Location
- Republic, MO
Frequently Asked Questions
What product was recalled? ▼
Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit. Recalled by ROi CPS LLC. Units affected: 134 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 22, 2023. Severity: Moderate. Recall number: Z-0315-2024.
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