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Terminated

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.

FDA Recall Z-2200-2008 · Posted 2008-09-11

Recalling FirmUtah Medical Products, Inc
Recall StatusTerminated
Product CodeHFN
Date Initiated2008-06-16
Date Terminated2011-06-23
Product Quantity300,000 units.

Reason for Recall

Possibility of compromised package sterility prior to the expiration date.

Firm 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.

Root Cause

Component change control

Distribution Pattern

Worldwide Distribution --- USA including states of CA, KS, MO, NC, NV, TX, VA, and WA and country of Japan.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K961424INTRAN 500Utah Medical Products, Inc. · 1996-07-10K955443INTRAN PLUSUtah Medical Products, Inc. · 1996-02-20K905563INTRAN PLUSUtah Medical Products, Inc. · 1991-06-19

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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