Z-2197-2008

CABG PACK, Surgical Convenience Kit, Sterile, Reorder #:K12T-02449B, Merit Medical Systems, Inc., 1600 West...

Name: Z-2197-2008 CABG PACK, Surgical Convenience Kit, Sterile, Reorder #:K12T-02449B, Merit Medical Systems, Inc., 1600 West...
Creator: Merit Medical Systems, Inc.
Published: 2008-03-14
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2008-03-14 / Terminated / root cause: packaging

FDA source

Merit Medical Systems, Inc. began a recall of CABG PACK, Surgical Convenience Kit, Sterile, Reorder #:K12T-02449B, Merit Medical Systems, Inc., 1600 West Merit Parkway, South Jordan, Utah 84095. A... on 2008-03-14. The reason FDA records is "Component of convenience kit may not be sterile". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2197-2008
Status: Terminated
Initiated: 2008-03-14
Posted: 2008-09-11
Terminated: 2008-09-09
Recalling firm: Merit Medical Systems, Inc.
Product: 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.
Product code: KDD Kit, Surgical Instrument, Disposable
Reason for recall: Component of convenience kit may not be sterile.
Root cause tag: packaging
FDA root cause: Packaging
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.
Quantity in commerce: 36 kits
Distribution: PA. No military, government, or foreign distribution.
Product codes and lots: Lot Number V583783

Product code KDD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)