Intran Plus, Disposable Intrauterine Pressure Catheter System, Part numbers IUP-400, IUP-400S, IUP-450, IUP-450S, IUP-50

FDA device recall Z-2200-2008 · posted 2008-09-11 · Terminated

Recall details

Recalling firm: Utah Medical Products, Inc
Reason for recall: Possibility of compromised package sterility prior to the expiration date.
Action taken: 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.
Root cause: Component change control
Status: Terminated
Product code: HFN
Quantity affected: 300,000 units.
Distribution: Worldwide Distribution --- USA including states of CA, KS, MO, NC, NV, TX, VA, and WA and country of Japan.
Date initiated: 2008-06-16
Date posted: 2008-09-11
Date terminated: 2011-06-23
Location: Midvale, UT

Recalls and clearances share one API, with change alerts when new recalls post.