Custom Fluid Management Set, Sterile, EO, Rx Only Used to transfer contrast media and saline from a container to a patients vascular system.
FDA Recall Z-0649-2017 · Posted 2016-11-21
Recalling FirmMerit Medical Systems, Inc.
Recall StatusTerminated
Product CodeFPA
Date Initiated2016-08-12
Date Terminated2017-05-09
Product Quantity107,341 total devices
Reason for Recall
Merit Medical Systems, Inc. announces a voluntary field action for Fluid Administration Sets due to a molding defect in the drip chamber.
Firm Action
Consignees were notified via an Urgent Product Recall Notice on 8/12/16 to:
1. Please immediately determine if any of the devices are within your facility, quarantine them, and discontinue use. 2. Ensure that all personnel to whom the devices were distributed are made aware of this field action. 3. Complete the Customer Response Form and return it to Merit Medical Systems with any affected products. If you have no affected products, please complete the Customer Response Form. 4. E-mail the completed Customer Response Form to Customer Service at [email protected], or fax to (801) 316-4880. 5. If you have any questions concerning this communication or for assistance arranging product return, please dont hesitate to contact your Merit Sales Representative or Vicki Biehn at [email protected] or at (801) 208-4260.
Root Cause
Component design/selection
Distribution Pattern
Nationwide Distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.