Recall Z-1911-2026 ยท OFB Catheter Guide Wire Kit
ARROW INTERNATIONAL, LLC
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 Catheteriz
| Date | Apr 22, 2026 (initiated Mar 11, 2026) |
| Status | Open, Classified |
| Reason | Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured |
| Root cause | Process control |
| Action | On 03/18/2026, the firm sent via FedEx-2-day an "URGENT MEDICAL DEVICE RECALL" Letter informing customers that Ferndale Laboratories issued a Field Safety Notice (FSN) to inform users of multiple complaints reporting the butyrate tubing of the Mastisol Liquid Adhesive vial cracked during actuation. According to the Ferndale Laboratories FSN, one lot of MASTISOL Liquid Adhesive was exposed to a double sterilization cycle which may have contributed to the butyrate tubing becoming brittle and susceptible to cracking during actuation. Medical Facilities should: 1. Immediately check inventory for |
| Quantity | 675 |
| Distribution | U.S. Nationwide distribution in the states of AZ, CA, GA, MA, ME, MI, OR, PA, and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.