Arrowg+ard Blue Plus four-lumen CVC kits recalled over adhesive manufacturing
Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC Kits are being recalled after a supplier notified the firm that the liquid adhesive was incorrectly manufactured.
What this means for you
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: FDA Class II recall of a central venous catheter kit built with incorrectly manufactured adhesive, a risk of harm with no injuries reported in the source.
Plain-English summary
The Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC Kit, REF ASK-45854-PUPM1, batch 33F25M0011, is being recalled, along with the additional product codes listed in the recall notice. The Arrowg+ard technology is intended to provide protection against catheter-related bloodstream infections. The action covers five units.
The recall follows a notice from a supplier that the liquid adhesive used in the device was incorrectly manufactured. The FDA classified the action as Class II.
Distribution was within the United States, in Arizona, California, Georgia, Massachusetts, Maine, Michigan, Oregon, Pennsylvania and Virginia. The kits are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the product code, UDI and batch number above, quarantine it, and follow the instructions issued by the manufacturer.
The recalled product
- Product
- Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC Kit REF ASK-45854-PUPM1 UDI code: (01)10801902159578(17)270531(11)251205(10)33F25M0011 The Arrowg+ard technology is intended to provide protection against catheter-related bloodstream infections (CRBSIs). It is not int
- Manufacturer
- ARROW INTERNATIONAL, LLC
- Affected units
- 5
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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