Recall Z-1913-2026 ยท BSO Catheter, Conduction, Anesthetic
ARROW INTERNATIONAL, LLC
FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET REF ASK-05502-BSM UDI code: (01)10801902209853(17)270831(11)251210(10)33F25K0409 The Arrow Epidural Catheter kit permits access to the epidural space for administration of epidural anesthetic. The epidural catheter kit is intended for use up to 72 hours. The Arrow Combined Spinal Anesthesia and Epidural Cat
| 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 | 190 |
| 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
| K140110 | FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET Teleflex, Inc., Mar 27, 2015 |