Warning
ARROW INTERNATIONAL Recalls MAC" Two-Lumen Central Venous Access Kit for use with 7
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-1916-2026Medical Device
ARROW INTERNATIONAL Recalls MAC" Two-Lumen Central Venous Access Kit for use with 7
ARROW INTERNATIONAL, LLC · Class II — Moderate Risk
Product Description
MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-11142-LC2 UDI code: (01)10801902206807(17)270531(11)251211(10)33F25M0670 The MAC Multi-Lumen Central Venous Access Device permits short-term (<30 days) venous access and catheter introduction to the central circulation.
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