Arrow Intra-Aortic Balloon Catheter Kit Recalled for Potential Helium Leak
Arrow International Inc is recalling 166 units of Intra-Aortic Balloon Catheter Kits due to a potential leak that allows helium to escape.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
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: The recall is classified as FDA Class II and involves a risk-of-harm product where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.
Plain-English summary
Arrow International Inc is recalling 166 units of the Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix (IAB), 8 Fr 40 cc, Model IAB-05840-LWS. The recall involves Lot Number KF1111796 with an expiration date of 11/30/2013.
The recall is being conducted because of a potential for a leak between the catheter and the bifurcate, which would allow helium to escape to the atmosphere. The affected products were distributed in the United States (including Arizona, New Jersey, Maine, Texas, and Washington) and in Germany.
Healthcare providers and consumers should stop using the affected products and contact Arrow International Inc for further instructions.
The recalled product
- Product
- Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix (IAB), 8 Fr 40 cc Model: IAB-05840-LWS
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 166
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 (1)
- Lot Number: KF1111796 Exp. Date: 11/30/2013
Distribution
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