Arrow International recalls Peel Away Sheath over Dilator due to packaging defect
Arrow International is recalling 416,055 units of Peel Away Sheath over Dilator because unsealed packaging may compromise product sterility.
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 involves a medical device where sterility may be compromised, creating a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
Arrow International Inc is recalling 416,055 units of Peel Away Sheath over Dilator (Product Codes PL-05041 and PL-05052). The recall is being conducted because product sterility may be compromised due to unsealed packaging.
The affected products were distributed in the United States and internationally, including Australia, Austria, Belgium, Canada, and the United Kingdom. Specific lot numbers for Product Code PL-05041 include 13F17G0050, 13F17J0360, and 13F17K0376. Specific lot numbers for Product Code PL-05052 include 13F17C0435, 13F17E0720, 13F17G0077, and 13F17G0514.
Consumers and healthcare providers should stop using the affected products and contact Arrow International Inc for further instructions or a replacement.
The recalled product
- Product
- Peel Away Sheath over Dilator; Product Codes: PL-05041 and PL-05052
- Manufacturer
- Arrow International Inc
- Affected units
- 416,055
Distribution
Part of a larger recall action
This product is one of 76 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 76 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 · sterility compromise
See all →- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighMedline Recalls Cataract Convenience Kits Due to Open Sterile Seals
FDA (Devices) · 2026-09-23
- HighMedline Myringotomy Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMedline Anesthesia Pain Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMaquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues
FDA (Devices) · 2026-09-23
Similar recalls
- SevereArrow International Recalls PICC Kits with Potential Peel-Away Sheath Defect
FDA (Devices) · 2015-09-02
- HighArrow Glide Thru Peel-Away Sheath Recall for Premature Hub Tab Detachment
FDA (Devices) · 2017-07-19
- HighArrow International Recalls Multi-Lumen Hemodialysis Catheterization Kits Due to Sterility Concerns
FDA (Devices) · 2018-04-18
- HighArrow PICC Kit Recall Due to Potential Sterility Seal Failure
FDA (Devices) · 2018-04-18
- HighArrow Recalls Percutaneous Sheath Introducer Sets Due to Packaging Damage
FDA (Devices) · 2016-03-16
- HighArrow International Recalls Certain Percutaneous Sheath Introducer Kits Due to Sterility Concerns
FDA (Devices) · 2018-04-18