Recall Z-1889-2017— Merit Medical Systems, Inc.

Name: FDA recall Z-1889-2017
Creator: U.S. Food and Drug Administration
Published: 2017-03-23

Class II · Terminated

Class II FDA medical device recall by Merit Medical Systems, Inc., initiated 2017-03-23, terminated 2017-09-26. It names one FDA 510(k) clearance: K875196. 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.. Reason: Merit Medical Systems announces a voluntary field action for the 1mL Medallion¿ Syringes due to a defect with the syringe plunger tip..

Recalling firm: Merit Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-03-23
Terminated: 2017-09-26
Firm location: South Jordan, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K875196 — DISPOSABLE CORONARY CONTROL SYRINGE 12CCMerit Medical Systems, Inc.·cleared 1988-02-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

Merit Medical Systems announces a voluntary field action for the 1mL Medallion¿ Syringes due to a defect with the syringe plunger tip.

Data sourced from openFDA. This site is unofficial and independent of the FDA.