Device product
1 mL Medallion¿ Syringe. Catalog Numbers: 701989001, K01-05197P, MSS011-YP, K01-07946P, MSS011, MSS011-LB, MSS011-R, MSS011-Y, MSS011P, MSS011-LBP, MSS011-DG, K08-02926AP, K01-07742P, K10-05457P.
Z-1889-2017
Product summary
- Event
- Event 76938
- Status
- Terminated
- Classification
- Class II
- Quantity
- 23,032 units
- Official record key
device-enforcement:Z-1889-2017
Official wording
Reason: Merit Medical Systems announces a voluntary field action for the 1mL Medallion¿ Syringes due to a defect with the syringe plunger tip.
Code information: Lot Numbers: B617173, H1082598, H1082648, H1082649, H1082809, H1085511, H1085645, H1092907, H1085649, H1097018, H1085658, H1085659, H1085735, H1089234, H1089419, H1090184, H1101188, H1101443.
Distribution pattern: Nationwide and other foreign consignees. No VA/govt/military or VA consignees.
Derived failure modes
-
Unknown
Merit Medical Systems announces a voluntary field action for the 1mL Medallion¿ Syringes due to a defect with the syringe plunger tip.