EpiFix Fixation Device for Epidural Catheters, REF 670M, Unomedical, Ltd., Great Britain.
FDA device recall Z-0629-2007 · posted 2007-03-15 · Terminated
Recall details
- Recalling firm
- Merit Medical Systems, Inc
- Reason for recall
- Sterility of some units may be compromised due to damaged packaging.
- Action taken
- Consignees were notified by letter on 02/23/2007. They were instructed to stop use of and return all affected product to Merit.
- Root cause
- Other
- Status
- Terminated
- Product code
- KMK
- Quantity affected
- 4223 units
- Distribution
- Worldwide, including USA, France, Germany, and United Kingdom.
- Date initiated
- 2007-02-15
- Date posted
- 2007-03-15
- Date terminated
- 2011-11-09
- Location
- South Jordan, UT
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