Recalls / —
—#154643
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.
- FDA product code
- FMF — Syringe, Piston
- Device class
- Class 2
- Medical specialty
- General Hospital
- 510(k) numbers
- K875196
- Affected lot / code info
- Lot Numbers: B617173, H1082598, H1082648, H1082649, H1082809, H1085511, H1085645, H1092907, H1085649, H1097018, H1085658, H1085659, H1085735, H1089234, H1089419, H1090184, H1101188, H1101443.
Why it was recalled
Merit Medical Systems announces a voluntary field action for the 1mL Medallion Syringes due to a defect with the syringe plunger tip.
Root cause (FDA determination)
Nonconforming Material/Component
Action the firm took
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.
Recalling firm
- Firm
- Merit Medical Systems, Inc.
- Address
- 1600 W Merit Pkwy South, Jordan, Utah 84095-2416
Distribution
- Distribution pattern
- Nationwide and other foreign consignees. No VA/govt/military or VA consignees.
Timeline
- Recall initiated
- 2017-03-23
- Terminated
- 2017-09-26
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #154643. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.