PERCUTANEOUS SHEATH INTRODUCER with 7.5 - 8 Fr. Catheter REF ASK-09903-MGH3 UDI code: recall (ARROW INTERNATIONAL, LLC)
Medical deviceClass IIOngoing
Summary: ARROW INTERNATIONAL, LLC is recalling 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: Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured.
What is being recalled
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.
Why
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
U.S. Nationwide distribution in the states of AZ, CA, GA, MA, ME, MI, OR, PA, and VA. (states named: Arizona, California, Georgia, Massachusetts, Maine, Michigan, Oregon, Pennsylvania, Virginia)
How to tell if yours is affected
Product code:ASK-09903-MGH3 UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J0352 Batch Number: 33F25K0130
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1912-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | March 11, 2026 |
| Reported | April 29, 2026 |
| Company | ARROW INTERNATIONAL, LLC |
| Company location | Morrisville, NC, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 115 |
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