Arrowgard Blue MAC Central Venous Access Kit recalled for defective adhesive
Arrow International is recalling the Arrowgard Blue MAC Two-Lumen Central Venous Access Kit due to incorrect manufacturing of the liquid adhesive by a supplier. The recall affects 95 units distributed in nine U.S. states.
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: The FDA classified this as a Class II recall. The source text does not report any illnesses, injuries, or adverse events; the defect is a manufacturing error in the adhesive component detected before widespread use. This matches the rubric criterion for moderate-severity recalls involving manufacturing defects without reported harm.
Plain-English summary
Arrow International, LLC is recalling the Arrowgard Blue MAC Two-Lumen Central Venous Access Kit for use with 7.5–8 Fr. Catheters (Product Code ASK-21142-DMC, UDI code: (01)10801902218930(17)270630(11)251211(10)33F25M0671, Batch Number: 33F25M0671). The device is intended for short-term venous access and catheter introduction to the central circulation via the jugular, subclavian, or femoral veins.
The recall was initiated after the manufacturer received notice from a supplier that the liquid adhesive component was incorrectly manufactured. The affected product consists of 95 units that were distributed nationwide in Arizona, California, Georgia, Massachusetts, Maine, Michigan, Oregon, Pennsylvania, and Virginia.
Patients or healthcare providers who have this device should contact Arrow International or their healthcare provider for further guidance. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- Arrowg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-21142-DMC UDI code: (01)10801902218930(17)270630(11)251211(10)33F25M0671 The MAC Multi-Lumen Central Venous Access Device with Arrowg+ard Blue technology permits…
- Manufacturer
- ARROW INTERNATIONAL, LLC
- Affected units
- 95
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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