Arrow PleuraSeal Thoracentesis Kit Recalled for Packaging Seal Defects
Arrow International Inc. is recalling PleuraSeal Thoracentesis Kits because product packaging may not be completely sealed.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is for a packaging-only problem (incomplete seal) with no reported injuries or illnesses, which aligns with the 'Low' severity criteria for packaging-only issues.
Plain-English summary
Arrow International Inc. is recalling ArrowClarke PleuraSeal Thoracentesis Kits. The recall is due to a defect where the product packaging may not be completely sealed.
The affected products are identified by the codes AK01000, AK-01000-J, AK-01000-T, and ASK-01000-CHP. These kits were distributed nationally.
Consumers and healthcare providers should check their inventory for these specific product codes and stop using the affected kits. They should contact Arrow International Inc. for further instructions on how to return or dispose of the products.
The recalled product
- Product
- ArrowClarke" PleuraSeal¿ Thoracentesis 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)
- AK01000 AK-01000-J AK-01000-T ASK-01000-CHP
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.
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