Custom Kit, Custom Angiographic Kit, REF: K05-YS1025, Sterile, Merit Medical Systems, Inc., South Jordan, Utah 84095.
FDA device recall Z-1699-2008 · posted 2008-09-04 · Terminated
Recall details
- Recalling firm
- Merit Medical Systems, Inc.
- Reason for recall
- Convenience kits may be non-sterile due to inadequate package sealing.
- Action taken
- Consignees were notified by letter (Urgent Product Recall) on 04/15/2008 and instructed to quarantine all affected kits for return to Merit. A Product Retrieval Form was included to be completed by the site representative. Please contact Greg Turner at 1-801-316-4998 or Jon Davis at 801-208-4497.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DQO
- Quantity affected
- 10 kits
- Distribution
- MO. Foreign distribution to Japan. No military or government distribution.
- Date initiated
- 2008-04-15
- Date posted
- 2008-09-04
- Date terminated
- 2008-09-03
- Location
- South Jordan, UT
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