ARROW INTERNATIONAL, LLC: Arrow Echogenic Introducer Needle REF ASK-04001-BWK2 UDI code: (01)10801902220315(17)261231(11)251210(10)33F25J0347 This device is inten
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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
- Arrow Echogenic Introducer Needle REF ASK-04001-BWK2 UDI code: (01)10801902220315(17)261231(11)251210(10)33F25J0347 This device is intended for injection or aspiration of fluids. The needle protection device covers the needle after use to help prevent needle sticks.
- Reason / hazard
- Due to receiving a notice from a supplier that the liquid adhesive were 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-04001-BWK2 UDI code: (01)10801902220315(17)261231(11)251210(10)33F25J0347 Batch Number: 33F25J0347
- Product quantity
- 85
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Morrisville
- State
- NC
- Country
- United States
- Event id
- 98618
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