Recall Z-1320-2014— Merit Medical Systems, Inc.

Name: FDA recall Z-1320-2014
Creator: U.S. Food and Drug Administration
Published: 2014-03-13

Class II · Terminated

Class II FDA medical device recall by Merit Medical Systems, Inc., initiated 2014-03-13, terminated 2014-07-07. It names one FDA 510(k) clearance: K875196. Product: Merit Custom Syringe Kit, Convenience Kit, I.R. Embolization Pack, K02-01010A, Sterile EO.. Reason: The products are labeled as sterile but were not sterilized..

Recalling firm: Merit Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-03-13
Terminated: 2014-07-07
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

Merit Custom Syringe Kit, Convenience Kit, I.R. Embolization Pack, K02-01010A, Sterile EO.

Reason for recall

The products are labeled as sterile but were not sterilized.

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