Recall Z-0649-2017 ยท FPA Set, Administration, Intravascular
Merit Medical Systems, Inc.
Custom Fluid Management Set, Sterile, EO, Rx Only Used to transfer contrast media and saline from a container to a patients vascular system.
| Date | Nov 21, 2016 (initiated Aug 12, 2016) |
| Status | Terminated |
| Reason | Merit Medical Systems, Inc. announces a voluntary field action for Fluid Administration Sets due to a molding defect in the drip chamber. |
| Root cause | Component design/selection |
| 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 RESPONSE@merit.com, or fax to (801) 316-4880. |
| Quantity | 107,341 total devices |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K915678 | MERIT ADMINISTRATION SET Merit Medical Systems, Inc., Jul 30, 1992 |