Warning
ARROW INTERNATIONAL Recalls FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS.
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #Z-1913-2026Medical Device
ARROW INTERNATIONAL Recalls FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS.
ARROW INTERNATIONAL, LLC · Class II — Moderate Risk
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
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
U.S. Nationwide distribution in the states of AZ, CA, GA, MA, ME, MI, OR, PA, and VA.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
Sources: FDA openFDA Enforcement Database