Recall
FDAHealthMarch 11, 2026

ARROW INTERNATIONAL, LLC — 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

⚠️ Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
March 11, 2026

U.S. Nationwide distribution in the states of AZ, CA, GA, MA, ME, MI, OR, PA, and VA.

What's affected?

Product
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.
Lot code
Product code:ASK-09903-MGH3 UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J0352 Batch Number: 33F25K0130

Additional details

Product code:ASK-09903-MGH3 UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J0352 Batch Number: 33F25K0130

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 115.

View original FDA notice →

Get Health recall alerts

Delivered to your inbox. Free. No account required.