Arrow International Recalls Certain Percutaneous Sheath Introducer Kits Due to Sterility Concerns
Arrow International Inc is recalling certain lots of percutaneous sheath introducer kits because they may not be completely sealed, meaning sterility cannot be guaranteed.
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 the hazard involves a risk of harm (loss of sterility) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Arrow International Inc is recalling certain lots of percutaneous sheath introducer kits. The recall is being conducted because the cardiovascular catheters in these kits may not be completely sealed, which means the sterility of the product cannot be guaranteed.
The affected products include various models of percutaneous sheath introducer kits designed for use with 7.5 - 8 Fr. catheters. Specific part numbers involved in the recall include ASK-09803-WBH1, ASK-09903-KH, ASK-09903-LC, ASK-09903-PHP, ASK-09907-LGH1, CDC-09803-1A, and CDC-09903-1A. The recall covers specific lot numbers, including 13F17C0208, 13F17F0162, 13F17F0231, 13F17E0382, 13F17F0206, 13F17D0049, 13F17A0052, 13F17C0390, 13F17A0123, 13F17E0014, 13F17E0455, 13F17F0289, 13F16M0274, 13F17E0040, 13F17E0227, and 13F17E0824.
These products were distributed in all 50 U.S. states and the District of Columbia, as well as in the Bahamas, Canada, Mexico, Panama, and Singapore. Healthcare providers and facilities should check their inventory for these specific part numbers and lot numbers. If the affected products are found, they should be removed from use and returned to the manufacturer or the appropriate regulatory authority as directed.
The recalled product
- Product
- (1) Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters, Part Number: ASK-09803-WBH1; (2) Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side…
- Manufacturer
- Arrow International Inc
- 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 (16)
- Lot Numbers: (1) 13F17C0208
- 13F17F0162
- (2) 13F17F0231
- (3) 13F17E0382
- 13F17F0206
- (4) 13F17D0049
- (5) 13F17A0052
- 13F17C0390
- (6) 13F17A0123
- 13F17E0014
- 13F17E0455
- 13F17F0289
- (7) 13F16M0274
- 13F17E0040
- 13F17E0227
- 13F17E0824
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 14 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 14 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 Ultra 8 Intra-Aortic Balloon Catheter Kit Recalled for Inflation Defect
FDA (Devices) · 2024-06-12
- SevereArrow UltraFlex Intra-Aortic Balloon Catheter Kit Recalled for Device Malfunction
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
- HighArrow Percutaneous Sheath Introducer Kits Recalled for Packaging Sterility Concerns
FDA (Devices) · 2018-06-06
- HighArrow International Recalls Percutaneous Sheath Introducer Kits Due to Sterility Concerns
FDA (Devices) · 2018-06-06
- ModerateArrow Percutaneous Sheath Introducer Kits Recalled for Packaging Sterility Issues
FDA (Devices) · 2018-06-06
- HighArrow-Flex Percutaneous Sheath Introducer Kit Recalled for Packaging Defect
FDA (Devices) · 2018-06-06
- ModerateArrow International Recalls Percutaneous Sheath Introducer Kits Missing Safety Checklists
FDA (Devices) · 2018-03-28
- ModerateArrow International Recalls Introducer Kits Due to Potential Sterility Compromise
FDA (Devices) · 2017-06-21