Medical Action Industries Pack Cath BHH Catheter Kit Recall
Medical Action Industries is recalling Pack Cath BHH catheter kits because the rotating adapter may unwind during use, causing a loose or full disconnection between the syringe and manifold.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class I recall. Per the rubric, Class I recalls receive a minimum score of 4 (Severe), as they carry the potential for serious adverse health consequences due to device malfunction that could result in improper medication delivery or patient harm.
Plain-English summary
Medical Action Industries, Inc. is recalling Pack Cath BHH catheter kits (REF: BHCA49K, Sterile EO, Rx Only, 5 kits per case). The rotating adapter in the syringe may unwind during use, resulting in a loose connection and/or full disconnection between the syringe and manifold.
Approximately 2030 kits with the following lot numbers have been distributed: 342509, 346066, 338434, 339423, 337365, 335489, 336189, and 336789. Distribution was to Arizona within the United States.
Healthcare providers and patients currently using or possessing affected kits should discontinue use and contact Medical Action Industries, Inc. for replacement or return instructions. Patients should consult with their healthcare provider if they have questions about their treatment.
The recalled product
- Product
- Medical Action Industries Inc. Pack Cath BHH, REF: BHCA49K, Sterile EO, Rx Only, QTY: 5/Case
- Manufacturer
- Medical Action Industries, Inc. 306
- Affected units
- 2,030
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 (8)
- UDI:20809160490294/ Lot numbers: 342509
- 346066
- 338434
- 339423
- 337365
- 335489
- 336189
- 336789
Distribution
Distributed in 1 state:
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