Warning
ARROW INTERNATIONAL Recalls PERCUTANEOUS SHEATH INTRODUCER with 7.5 - 8 Fr
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-1912-2026Medical Device
ARROW INTERNATIONAL Recalls PERCUTANEOUS SHEATH INTRODUCER with 7.5 - 8 Fr
ARROW INTERNATIONAL, LLC · Class II — Moderate Risk
Product Description
PERCUTANEOUS SHEATH INTRODUCER with 7.5 - 8 Fr. Catheter REF ASK-09903-MGH3 UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J0352 The Arrow¿ percutaneous sheath introducer permits 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.
411 Press Analysis
A Class II FDA recall has been issued for a medical device from ARROW INTERNATIONAL, LLC, initiated on March 11, 2026. Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured. This recall covers 115, distributed in AZ, CA, GA, MA, ME, MI, OR, PA, and VA. While not the highest severity, consumers should exercise caution and stop using the product until the recall is resolved.
Sources: FDA openFDA Enforcement Database
This recall appears in: Medical Device Defects and Arrow International recalls.