FDA DevicesClass II
PERCUTANEOUS SHEATH INTRODUCER with 7.5 - 8 Fr. Catheter REF ASK-09903-MGH3 UDI...
Published: April 29, 2026Recall ID: Z-1912-2026Category: devicesCountry: US
Reason for Recall / Hazard
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
Product Description & Identification
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.
Affected Products
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.
Additional Source Details
| Field | Value |
|---|---|
| City | Morrisville |
| State | NC |
| Event id | 98618 |
| Address 1 | 3015 Carrington Mill Blvd |
| Address 2 | N/A |
| Code info | Product code:ASK-09903-MGH3 UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J0352 Batch Number: 33F25K0130 |
| Postal code | 27560-5437 |
| Report date | 20260429 |
| Product type | Devices |
| Product quantity | 115 |
| Reason for recall | Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260311 |
| Initial firm notification | Letter |
| Center classification date | 20260422 |
Overview
- Recalling FirmARROW INTERNATIONAL, LLC
- StatusOngoing
- Risk LevelClass II
- DistributionU.S. Nationwide distribution in the states of AZ, CA, GA, MA, ME, MI, OR, PA, and VA.