Z-2200-2008

Intran Plus, Disposable Intrauterine Pressure Catheter System, Part numbers IUP-400, IUP-400S, IUP-450...

Name: Z-2200-2008 Intran Plus, Disposable Intrauterine Pressure Catheter System, Part numbers IUP-400, IUP-400S, IUP-450...
Creator: Utah Medical Products, Inc
Published: 2008-06-16
License: https://open.fda.gov/license/

Utah Medical Products, Inc / initiated 2008-06-16 / Terminated / root cause: packaging

FDA source

Utah Medical Products, Inc began a recall of Intran Plus, Disposable Intrauterine Pressure Catheter System, Part numbers IUP-400, IUP-400S, IUP-450, IUP-450S, IUP-500, IUP-550, IUP-600, IUP-600S, IUP-650... on 2008-06-16. The reason FDA records is "Possibility of compromised package sterility prior to the expiration date". 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-2200-2008
Status: Terminated
Initiated: 2008-06-16
Posted: 2008-09-11
Terminated: 2011-06-23
Recalling firm: Utah Medical Products, Inc
Product: Intran Plus, Disposable Intrauterine Pressure Catheter System, Part numbers IUP-400, IUP-400S, IUP-450, IUP-450S, IUP-500, IUP-550, IUP-600, IUP-600S, IUP-650, IUP-650S, IUP-700, IUP-750, Sterile, Single Use, Utah Medical Products Inc., 7043 South 300 West, Midvale, Utah 84047.
Product code: HFN Transducer, Pressure, Intrauterine
Reason for recall: Possibility of compromised package sterility prior to the expiration date.
Root cause tag: packaging
FDA root cause: Component change control
Action: All consignees were notified by a faxed Recall Notice letter beginning on 6/16/2008. Customers were asked to return all unused product for immediate replacement with units that have a protective barrier within the tray packaging. The firm cautioned customers to visually inspect packaging before use. Follow-up phone calls will be made the following week.
Quantity in commerce: 300,000 units.
Distribution: Worldwide Distribution --- USA including states of CA, KS, MO, NC, NV, TX, VA, and WA and country of Japan.
Product codes and lots: Lot numbers less than 1072755. Also 1080086, 1080087, 1080088, 1080089, 1080091, 1080093, 1080095, 1080245, 1080246, 1080247, 1080248, 1080249, 1080250, 1080266, 1080296, 1080297, 1080298, 1080299, 1080301, 1080302, 1080393, 1080394, 1080395, 1080432, 1080610, 1080669, and 1080721.

Product code HFN

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)