Notice names this product. ARROW INTERNATIONAL’s FLEXTIP PLUS EPIDURAL CATHETER is named in FDA Class II recall Z-1913-2026.
Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies.Agency-reported hazard: Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured Identifying details: Product code:ASK-05502-BSM UDI code: (01)10801902209853(17)270831(11)251210(10)33F25K0409 Batch Number: 33F25K0409. Units affected: 190. Status: Ongoing.
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This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
U.S. Nationwide distribution in the states of AZ, CA, GA, MA, ME, MI, OR, PA, and VA.
Agency product description and boundaries
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..
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If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.