Recall Z-1889-2017 ยท FMF Syringe, Piston
Merit Medical Systems, Inc.
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.
| Date | Mar 23, 2017 |
| Status | Terminated |
| Reason | Merit Medical Systems announces a voluntary field action for the 1mL Medallion Syringes due to a defect with the syringe plunger tip. |
| Root cause | Nonconforming Material/Component |
| Action | Consignees began receiving notification via letter on March 23, 2017 to immediately stop using or distributing the affected lots and return them back to Merit. If there are any questions, contact Merit Customer Service at (801) 208-4381. |
| Quantity | 23,032 units |
| Distribution | Nationwide and other foreign consignees. No VA/govt/military or VA consignees. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K875196 | DISPOSABLE CORONARY CONTROL SYRINGE 12CC Merit Medical Systems, Inc., Feb 11, 1988 |