Warning
ARROW INTERNATIONAL Recalls ARROW RADIAL ARTERY CATHETERIZATION KIT REF.
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-1911-2026Medical Device
ARROW INTERNATIONAL Recalls ARROW RADIAL ARTERY CATHETERIZATION KIT REF.
ARROW INTERNATIONAL, LLC · Class II — Moderate Risk
Product Description
ARROW RADIAL ARTERY CATHETERIZATION KIT REF ASK-04220-UCL1 UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J0352 REF ASK-04020-EUH2 UDI code: (01)10801902213379(17)270731(11)251218(10)33F25J0869 REF ASK-04020-FMC UDI code: (01)10801902212099(17)270731(11)251218(10)33F25J0870 REF ASK-04020-MMC UDI code: (01)10801902117769(17)271130(11)251211(10)33F25J0880 The Arrow Arterial Catheterization Device permits access to the peripheral arterial circulation or to other small vessels.
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