ARROW INTERNATIONAL, LLC: MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-11142-LC2 UDI code: (01)10801902206807(17)270531(11)251
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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
- MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-11142-LC2 UDI code: (01)10801902206807(17)270531(11)251211(10)33F25M0670 The MAC Multi-Lumen Central Venous Access Device permits short-term (<30 days) 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-11142-LC2 UDI code: (01)10801902206807(17)270531(11)251211(10)33F25M0670 Batch Number: 33F25M0670
- Product quantity
- 90
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Morrisville
- State
- NC
- Country
- United States
- Event id
- 98618
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