← FDA ENFORCEMENT
Z-1913-2026Class II

ARROW INTERNATIONAL, LLC

Recalling firm
ARROW INTERNATIONAL, LLC
Product type
Device
Status
Ongoing
Report date
2026-04-29
Distribution
U.S. Nationwide distribution in the states of AZ, CA, GA, MA, ME, MI, OR, PA, and VA.
Firm state
NC
Product quantity
190
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change Control
Reason for recall

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

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..

Code / lot info

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

Other recalls SPEQ maps to Documentation & Change Control
2026-07-22Class ID'Dioses Fruit Pops, Inc.2026-07-22Class IIFayus Inc.2026-07-22Class ID'Dioses Fruit Pops, Inc.2026-07-22Class ID'Dioses Fruit Pops, Inc.
See all Documentation & Change Control recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.