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
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- ARROW INTERNATIONAL, LLC
- 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 / hazard
- Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- U.S. Nationwide distribution in the states of AZ, CA, GA, MA, ME, MI, OR, PA, and VA.
- Recall initiated
- 2026-03-11
- Code info
- Product code:ASK-09903-MGH3 UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J0352 Batch Number: 33F25K0130
- Product quantity
- 115
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Morrisville
- State
- NC
- Country
- United States
- Event id
- 98618
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