Device 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.
Z-1916-2026
Product summary
- Event
- Event 98618
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 90
- Official record key
device-enforcement:Z-1916-2026
Official wording
Reason: Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
Code information: Product Code: ASK-11142-LC2 UDI code: (01)10801902206807(17)270531(11)251211(10)33F25M0670 Batch Number: 33F25M0670
Distribution pattern: U.S. Nationwide distribution in the states of AZ, CA, GA, MA, ME, MI, OR, PA, and VA.
Derived failure modes
-
Unknown
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured