Cardiovascular Convenience Kit Recalled for Inadequate Chest Drain Instructions
ROi CPS LLC is recalling Regard CV PK cardiovascular convenience kits due to insufficient instructions for proper chest drain catheter and tube connection setup. 134 units were distributed in Missouri.
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: This is an FDA Class II recall of a medical device used for chest drainage. Although no illnesses or injuries have been reported, inadequate instructions for use on a critical medical device present a risk of harm from improper setup, meeting the rubric criterion for high-risk products without reported injury.
Plain-English summary
ROi CPS LLC is recalling Regard CV PK cardiovascular convenience kits (Item Numbers 880289014 and 880289015) due to inadequate instructions for use. The FDA classified this as a Class II recall.
The recalled kits contain Gentige Chest Drain Products. The instructions for use do not provide sufficient precaution guidance for the proper setup of catheter connections and patient tube connections when using single collection chamber chest drains.
The recall affects 134 units distributed in Missouri. Affected units include Lot Numbers 94114 and 95436 (UDI/DI 10194717111702) and Lot Number 96442 (UDI/DI 10194717117049).
Healthcare providers and patients with these kits should contact ROi CPS LLC for instructions on device replacement or return.
The recalled product
- Product
- Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit
- Manufacturer
- ROi CPS LLC
- Hazard
- inadequate-instructions
- improper-setup
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 (5)
- a) UDI/DI 10194717111702
- Lot Numbers: 94114
- 95436
- b) UDI/DI 10194717117049
- Lot Numbers: 96442
Distribution
Distributed in 1 state:
- MO
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