Z-1808-2008

Arnot-Ogden Med Ctr Hip Pack, REF: K12T-02160A, Sterile, Merit Medical Systems, Inc., 1600 West Merit...

Name: Z-1808-2008 Arnot-Ogden Med Ctr Hip Pack, REF: K12T-02160A, Sterile, Merit Medical Systems, Inc., 1600 West Merit...
Creator: Merit Medical Systems, Inc.
Published: 2008-04-10
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2008-04-10 / Terminated / root cause: packaging

FDA source

Merit Medical Systems, Inc. began a recall of Arnot-Ogden Med Ctr Hip Pack, REF: K12T-02160A, Sterile, Merit Medical Systems, Inc., 1600 West Merit Parkway, South Jordan, Utah 84095. A combination of... on 2008-04-10. The reason FDA records is "Sterility Compromised - Component of convenience kit was recalled by its manufacturer for non-sterility". 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-1808-2008
Status: Terminated
Initiated: 2008-04-10
Posted: 2008-09-19
Terminated: 2008-09-22
Recalling firm: Merit Medical Systems, Inc.
Product: Arnot-Ogden Med Ctr Hip Pack, REF: K12T-02160A, Sterile, 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: Sterility Compromised - Component of convenience kit was recalled by its manufacturer for non-sterility.
Root cause tag: packaging
FDA root cause: Packaging
Action: 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.
Quantity in commerce: 30 kits
Distribution: Class II Recall - Nationwide Distribution --- including state of NY.
Product codes and lots: Lot Number V477096

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)