Arrow Glide Thru Peel-Away Sheath Recall for Premature Hub Tab Detachment
Arrow International is recalling Glide Thru Peel-Away Sheath/Dilator Introducers because hub tabs may detach prematurely during use.
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 with a functional defect that could compromise the procedure, but the source text does not report any injuries or illnesses, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Arrow International Inc is recalling additional lots of the Arrow Glide Thru Peel-Away Sheath/Dilator Introducer. This action is part of an active recall. The product is a medical device used in catheter procedures.
The recall is due to the possibility that the catheter peel-away component hub tabs may prematurely detach when a practitioner begins to peel apart the sheath body from the catheter. The source text does not report any specific injuries or illnesses associated with this defect.
Approximately 9,037 units were distributed in the U.S. and 4,505 units internationally. U.S. distribution included South Carolina, Alabama, New Jersey, Indiana, Massachusetts, Georgia, California, Pennsylvania, Arizona, Virginia, and Washington. International distribution included Bangkok. The affected product is identified by Device Listing # D184260 and Material # PL-01055.
The recalled product
- Product
- Arrow Glide Thru Peel-Away Sheath/Dilator Introducer
- 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 (1)
- Device Listing # D184260 Material # PL-01055
Distribution
Part of a larger recall action
This product is one of 2 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 2 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 · premature detachment
See all →- HighArrow Recalls EVOLUTION Pressure Injectable PICC Catheters Due to Hub Tab Detachment
FDA (Devices) · 2017-07-19
- ModerateArrow International Recalls PICC Kits Due to Hub Tab Detachment
FDA (Devices) · 2015-11-11
- SevereArrow International Recalls PICC Kits with Potential Peel-Away Sheath Defect
FDA (Devices) · 2015-09-02
Similar recalls
- SevereArrow International Recalls PICC Kits with Potential Peel-Away Sheath Defect
FDA (Devices) · 2015-09-02
- SevereArrow Access Kit Recalled Due to Needlestick Injury Risk
FDA (Devices) · 2017-06-14
- HighArrow Percutaneous Sheath Introducer Kits Recalled for Dilator Tip Damage
FDA (Devices) · 2014-06-11
- ModerateArrow International Recalls PICC Kits Due to Hub Tab Detachment
FDA (Devices) · 2015-11-11
- SevereArrow International Recalls Access Kits Due to Needlestick Injury Risk
FDA (Devices) · 2017-06-14
- HighArrow International recalls Peel Away Sheath over Dilator due to packaging defect
FDA (Devices) · 2018-06-06