Recall archive / FDA device enforcement
PERCUTANEOUS SHEATH INTRODUCER with 7.5 - 8 Fr. Catheter REF ASK-09903-MGH3 UDI code: (01)10801902159127(17)270331(11... — FDA record Z-1912-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Mar 11, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Reason
- Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
- Classification
- Class II
- Recalling firm
- ARROW INTERNATIONAL, LLC
- Quantity
- 115
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1912-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Product code:ASK-09903-MGH3 UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J0352 Batch Number: 33F25K0130 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
U.S. Nationwide distribution in the states of AZ, CA, GA, MA, ME, MI, OR, PA, and VA.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Apr 29, 2026
- Recall initiation date
- Mar 11, 2026
- Center classification date
- Apr 22, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.