CABG PACK, Surgical Convenience Kit, Sterile, Reorder #:K12T-02449B, Merit Medical Systems, Inc., 1600 West Merit Parkwa
FDA device recall Z-2197-2008 · posted 2008-09-11 · Terminated
Recall details
- Recalling firm
- Merit Medical Systems, Inc.
- Reason for recall
- Component of convenience kit may not be sterile.
- Action taken
- The sole direct account (distributor) and the sole end-user were notified by letter on 03/13-14/2008. Direct account was instructed to return any affected product still in inventory. End user was advised to discard the blades or re-sterilize them according to blade manufacturer's instructions, which were included. For assistance, contact Merit Medical at 1-801-208-4349.
- Root cause
- Packaging
- Status
- Terminated
- Product code
- KDD
- Quantity affected
- 36 kits
- Distribution
- PA. No military, government, or foreign distribution.
- Date initiated
- 2008-03-14
- Date posted
- 2008-09-11
- Date terminated
- 2008-09-09
- Location
- South Jordan, UT
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