Arnot-Ogden Med Ctr Hip Pack, REF: K12T-02160A, Sterile, Merit Medical Systems, Inc., 1600 West Merit Parkway, South Jor
FDA device recall Z-1808-2008 · posted 2008-09-19 · Terminated
Recall details
- Recalling firm
- Merit Medical Systems, Inc.
- Reason for recall
- Sterility Compromised - Component of convenience kit was recalled by its manufacturer for non-sterility.
- Action taken
- Site Visit - There is only one consignee that received product. That single consignee was visited by Merit sales rep on 04/14/2008 with instructions to discontinue use and quarantine any affected product. No Hemovac inventory and no affected kits remained in Merit's inventory at the time of notification from Zimmer. The consignee site representative verified that all 60 of the affected kits received by them had already been used.
- Root cause
- Packaging
- Status
- Terminated
- Product code
- KDD
- Quantity affected
- 30 kits
- Distribution
- Class II Recall - Nationwide Distribution --- including state of NY.
- Date initiated
- 2008-04-10
- Date posted
- 2008-09-19
- Date terminated
- 2008-09-22
- Location
- South Jordan, UT
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