Z-1912-2026 Class II Ongoing
FDA device recall Z-1912-2026 was initiated by ARROW INTERNATIONAL, LLC on March 11, 2026 and is designated Class II. Reason for recall: Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured The recall status is ongoing. Affected quantity: 115.
Recall Details
- Product Type
- Devices
- Report Date
- April 29, 2026
- Initiation Date
- March 11, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 115
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
Distribution Pattern
U.S. Nationwide distribution in the states of AZ, CA, GA, MA, ME, MI, OR, PA, and VA.
Code Information
Product code:ASK-09903-MGH3 UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J0352 Batch Number: 33F25K0130