CABG PACK, Surgical Convenience Kit, Sterile, Reorder #:K12T-02449B, Merit Medical Systems, Inc., 1600 West Merit Parkway, South Jordan, Utah 84095. A combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the products' intended uses.
FDA Recall Z-2197-2008 · Posted 2008-09-11
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Recalling FirmMerit Medical Systems, Inc.
Recall StatusTerminated
Product CodeKDD
Date Initiated2008-03-14
Date Terminated2008-09-09
Product Quantity36 kits
Reason for Recall
Component of convenience kit may not be sterile.
Firm Action
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
Distribution Pattern
PA. No military, government, or foreign distribution.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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