Arrow Echogenic Introducer Needle REF ASK-04001-BWK2 Medical Device Recall
Arrow International is recalling 85 units of the Arrow Echogenic Introducer Needle due to incorrect manufacturing of the liquid adhesive used in the device.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall of a medical device. No illnesses, injuries, or deaths are reported in the source text, and the hazard is a manufacturing defect in adhesive that could affect device function rather than a direct safety threat with confirmed harm.
Plain-English summary
Arrow International, LLC is recalling 85 units of the Arrow Echogenic Introducer Needle, model REF ASK-04001-BWK2 (UDI code: (01)10801902220315(17)261231(11)251210(10)33F25J0347, Batch Number: 33F25J0347). The device is intended for injection or aspiration of fluids and includes a needle protection device designed to cover the needle after use to help prevent needle sticks.
The recall was initiated due to receiving notice from a supplier that the liquid adhesive used in the device was incorrectly manufactured. This defect in the adhesive could compromise the function of the needle protection mechanism.
The recalled devices were distributed nationwide in Arizona, California, Georgia, Massachusetts, Maine, Michigan, Oregon, Pennsylvania, and Virginia. Patients or healthcare providers who have this product should contact Arrow International for further instructions regarding the recalled units.
The recalled product
- Product
- Arrow Echogenic Introducer Needle REF ASK-04001-BWK2 UDI code: (01)10801902220315(17)261231(11)251210(10)33F25J0347 This device is intended for injection or aspiration of fluids. The needle protection device covers the needle after use to help prevent needle sticks.
- Manufacturer
- ARROW INTERNATIONAL, LLC
- Affected units
- 85
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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