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.
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 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.
See all 3 products in this recall →Related recalls
Same manufacturer · Arrow International Inc
See all →- HighArrow Arterial Kits Recalled Due to Open Packaging Seals
FDA (Devices) · 2024-10-02
- SevereIntra-Aortic Balloon Catheter Kit Recalled for Inflation and Structural Defects
FDA (Devices) · 2024-06-12
- SevereArrow UltraFlex Intra-Aortic Balloon Catheter Kit Recalled for Device Malfunction
FDA (Devices) · 2024-06-12
- SevereArrow Ultra 8 Intra-Aortic Balloon Catheter Kit Recalled for Inflation Defect
FDA (Devices) · 2024-06-12
- SevereARROW QuickFlash Radial Artery Catheters Recalled for Defective Component
FDA (Devices) · 2024-03-27
Same hazard · packaging defect
See all →- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- ModerateAmneal Recalls Estradiol Gel Packets Due to Empty or Partially Full Containers
FDA (Drugs) · 2026-10-07
- HighCardinal Health Recalls Presource Convenience Kits Due to Seal Defects
FDA (Devices) · 2026-09-30
- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighCardinal Health Recalls Presource Convenience Kits Due to Potential Seal Defects
FDA (Devices) · 2026-09-30
Similar recalls
- HighArrow Arterial Catheterization Kit Recalled for Unsealed Packaging
FDA (Devices) · 2018-06-06
- HighArrow International Recalls Central Venous Catheter Kits Due to Packaging Defect
FDA (Devices) · 2018-06-06
- HighArrow Radial Artery Catheterization Kits Recalled for Packaging Defects
FDA (Devices) · 2018-06-06
- ModerateArrow International Recalls Central Venous Catheter Kits Due to Packaging Issues
FDA (Devices) · 2018-06-06
- HighArrow PICC Kit Recall Due to Potential Sterility Seal Failure
FDA (Devices) · 2018-04-18
- HighArrow Central Venous Catheterization Kit Recalled for Unsealed Packaging
FDA (Devices) · 2018-06-06