Recalls / —
—#149424
Product
Merit Inflation Syringe Kit. Catalog Number KOS-02857
- FDA product code
- MAV — Syringe, Balloon Inflation
- Device class
- Class 2
- Medical specialty
- Cardiovascular
- 510(k) numbers
- K122321
- Affected lot / code info
- Lot Numbers: H959038, H970334, H984351.
Why it was recalled
Merit Medical Systems, Inc. announces a voluntary field action for Merit Inflation Syring Kit due to unit labels missing required device labeling information.
Root cause (FDA determination)
Labeling design
Action the firm took
Merit Medical Inc. notified all affected customers on August 25, 2016, via verbal and written notification to return the affected units. The returned units will be re-labeled. For further questions, please call (801) 316-3690.
Recalling firm
- Firm
- Merit Medical Systems, Inc.
- Address
- 1600 W Merit Pkwy South, Jordan, Utah 84095-2416
Distribution
- Distribution pattern
- One consignee located in CA. No Canadian, other foreign or VA/govt/military consignees.
Timeline
- Recall initiated
- 2016-08-25
- Terminated
- 2016-12-01
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #149424. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.