Recall Z-0162-2015— Merit Medical Systems, Inc.

Name: FDA recall Z-0162-2015
Creator: U.S. Food and Drug Administration
Published: 2014-09-26

Class II · Terminated

Class II FDA medical device recall by Merit Medical Systems, Inc., initiated 2014-09-26, terminated 2014-11-19. It names one FDA 510(k) clearance: K082613. Product: Merit Maestro Microcatheter, 2.4F 130cm Straight, REF28MC24130ST, Rx Only, Non-pyrogenic Sterile if package is unopened or undamaged.. Reason: These microcatheters were packaged with a 2.8 F distal tip, rather than the labeled 2.4 F..

Recalling firm: Merit Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-09-26
Terminated: 2014-11-19
Firm location: South Jordan, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K082613 — MERIT MICROCATHETERMerit Medical Systems, Inc.·cleared 2008-12-30

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 Maestro Microcatheter, 2.4F 130cm Straight, REF28MC24130ST, Rx Only, Non-pyrogenic Sterile if package is unopened or undamaged.

Reason for recall

These microcatheters were packaged with a 2.8 F distal tip, rather than the labeled 2.4 F.

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