Z-1913-2026 Class II Ongoing

Recalled by ARROW INTERNATIONAL, LLC — Morrisville, NC

Recall Details

Product Type
Devices
Report Date
April 29, 2026
Initiation Date
March 11, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
190

Product Description

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 Catheterization products permit access to subarachnoid and epidural spaces. The Arrow Single Shot Epidural product permits access to the epidural space..

Reason for Recall

Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured

Distribution Pattern

U.S. Nationwide distribution in the states of AZ, CA, GA, MA, ME, MI, OR, PA, and VA.

Code Information

Product code:ASK-05502-BSM UDI code: (01)10801902209853(17)270831(11)251210(10)33F25K0409 Batch Number: 33F25K0409