Arrow Percutaneous Sheath Introducer Catheter Recall Due to Adhesive Defect
Arrow International is recalling 115 units of its percutaneous sheath introducer with 7.5–8 Fr catheter because the liquid adhesive was incorrectly manufactured by a supplier. The product is used for venous access and central circulation catheterization.
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: This is an FDA Class II medical device recall involving a manufacturing defect (incorrect liquid adhesive) in a device used for central vascular access. Although no reported illnesses or injuries are stated in the source, the risk-of-harm nature of an adhesive defect in a critical vascular access device and the Class II designation warrant a High severity rating.
Plain-English summary
Arrow International, LLC is recalling percutaneous sheath introducer devices with 7.5–8 Fr catheter (model ASK-09903-MGH3) distributed nationwide. The recall was initiated after the manufacturer received notice from a supplier that the liquid adhesive used in the devices was incorrectly manufactured.
The affected devices were distributed in Arizona, California, Georgia, Massachusetts, Maine, Michigan, Oregon, Pennsylvania, and Virginia. A total of 115 units are involved in this recall. The product is intended for venous access and catheter introduction to the central circulation.
If you have received or are using this product, contact Arrow International, LLC for instructions on return or replacement. Do not use the device if you have any questions about whether your unit is affected.
The recalled product
- Product
- PERCUTANEOUS SHEATH INTRODUCER with 7.5 - 8 Fr. Catheter REF ASK-09903-MGH3 UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J0352 The Arrow¿ percutaneous sheath introducer permits venous access and catheter introduction to the central circulation.
- Manufacturer
- ARROW INTERNATIONAL, LLC
- Affected units
- 115
Distribution
Part of a larger recall action
This product is one of 8 recalled by ARROW INTERNATIONAL, LLC 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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