Device product
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..
Z-1913-2026
Product summary
- Event
- Event 98618
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 190
- Official record key
device-enforcement:Z-1913-2026
Official wording
Reason: Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
Code information: Product code:ASK-05502-BSM UDI code: (01)10801902209853(17)270831(11)251210(10)33F25K0409 Batch Number: 33F25K0409
Distribution pattern: U.S. Nationwide distribution in the states of AZ, CA, GA, MA, ME, MI, OR, PA, and VA.
Derived failure modes
-
Unknown
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured