Arrow International Pneumothorax Kit Recalled for Packaging Seal Issues
Arrow International Inc is recalling Pneumothorax Kits because the product packaging may not be completely sealed.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class II, but the specific defect is a packaging seal issue with no reported injuries or illnesses, fitting the criteria for a low-severity packaging-only problem.
Plain-English summary
Arrow International Inc is recalling Pneumothorax Kits due to a potential defect in the product packaging. The recall was initiated because the packaging may not be completely sealed.
The affected products were distributed nationally. The specific codes associated with this recall are AK 01500 and CA 01500.
Consumers who possess these products should stop using them and contact the recalling firm for further instructions or a replacement.
The recalled product
- Product
- Pneumothorax Kit
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Surgical Kits
- Hazard
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)
- AK 01500 CA 01500
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 recalled by Arrow International Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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