Recall Z-0635-2017— Merit Medical Systems, Inc.
Class II · Terminated
Class II FDA medical device recall by Merit Medical Systems, Inc., initiated 2016-09-23, terminated 2017-03-27. FDA's recall record names no specific 510(k) clearance for this event. Product: Procedure Kit. Catalog Numbers K12-04830B and K12-YP030A. Reason: Merit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedure Kits due to a compromised sterile barrier..
- Recalling firm
- Merit Medical Systems, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-09-23
- Terminated
- 2017-03-27
- Firm location
- South Jordan, UT, United States
Product description
Procedure Kit. Catalog Numbers K12-04830B and K12-YP030A
Reason for recall
Merit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedure Kits due to a compromised sterile barrier.
Data sourced from openFDA. This site is unofficial and independent of the FDA.