Arrow Pressure Injectable Central Venous Catheters Recalled
Arrow International is recalling 395 pressure injectable central venous catheters across nine U.S. states due to incorrect manufacturing of the liquid adhesive by a supplier.
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 with no reported illnesses or injuries mentioned in the source text. The hazard—incorrectly manufactured liquid adhesive—is a manufacturing defect of a medical device, but without evidence of harm, this meets the criteria for Moderate severity per the rubric.
Plain-English summary
Arrow International, LLC is recalling Arrow, ArrowG+ARD, and ArrowG+ARD Blue Plus pressure injectable central venous catheters with 395 units affected. The recall was initiated after the company received notice from a supplier that the liquid adhesive used in these catheters was incorrectly manufactured.
These catheters are designed to provide protection against catheter-related bloodstream infections (CRBSIs) and are not intended for treatment of existing infections or long-term use beyond 30 days. The affected products were distributed nationwide to healthcare facilities in Arizona, California, Georgia, Massachusetts, Maine, Michigan, Oregon, Pennsylvania, and Virginia.
Patients and healthcare providers who have these catheters should contact Arrow International, LLC for instructions regarding the recalled units. The affected product codes are ASK-42802-PLH, ASK-45703-MGH, ASK-42854-MGH, and ASK-45854-MGH, along with their associated batch numbers and UDI codes.
The recalled product
- Product
- ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER REF ASK-42802-PLH UDI code: (01)10801902133110(17)261231(11)251211(10)33F25L0140 REF ASK-45703-MGH UDI code: (01)10801902223675(17)261231(11)251209(10)33F25L0143 REF ASK-42854-MGH…
- Manufacturer
- ARROW INTERNATIONAL, LLC
- Affected units
- 395
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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