Recall Z-1911-2026— ARROW INTERNATIONAL, LLC
Class II · Ongoing
Class II FDA medical device recall by ARROW INTERNATIONAL, LLC, initiated 2026-03-11. FDA's recall record names no specific 510(k) clearance for this event. Product: ARROW RADIAL ARTERY CATHETERIZATION KIT REF ASK-04220-UCL1 UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J0352 REF ASK-04020-EUH2 UDI code: (01)10801902213379(17)270731(11)251218(10)33F25J0869 REF ASK-04020-FMC UDI code: (01)10801902212099(17)270731(11)251218(10)33F25J0870 REF ASK-04020-MMC UDI code: (01)10801902117769(17)271130(11)251211(10)33F25J0880 The Arrow Arterial Catheterization Device permits access to the peripheral arterial circulation or to other small vessels.. Reason: Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured.
- Recalling firm
- ARROW INTERNATIONAL, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-03-11
- Firm location
- Morrisville, NC, United States
Product description
ARROW RADIAL ARTERY CATHETERIZATION KIT REF ASK-04220-UCL1 UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J0352 REF ASK-04020-EUH2 UDI code: (01)10801902213379(17)270731(11)251218(10)33F25J0869 REF ASK-04020-FMC UDI code: (01)10801902212099(17)270731(11)251218(10)33F25J0870 REF ASK-04020-MMC UDI code: (01)10801902117769(17)271130(11)251211(10)33F25J0880 The Arrow Arterial Catheterization Device permits access to the peripheral arterial circulation or to other small vessels.
Reason for recall
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
Data sourced from openFDA. This site is unofficial and independent of the FDA.