Custom Fluid Management Set, Sterile, EO, Rx Only Used to transfer contrast media and saline from a container to a patie
FDA device recall Z-0649-2017 · posted 2016-11-21 · Terminated
Recall details
- Recalling firm
- Merit Medical Systems, Inc.
- 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.
- Action taken
- 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. 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 vbiehn@merit.com or at (801) 208-4260.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 107,341 total devices
- Distribution
- Nationwide Distribution.
- Date initiated
- 2016-08-12
- Date posted
- 2016-11-21
- Date terminated
- 2017-05-09
- Location
- South Jordan, UT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MERIT ADMINISTRATION SET (K915678) | Merit Medical Systems, Inc. | 1992-07-30 |