FDA Medical Device Recalls (openFDA)
Utah Medical Products, Inc: 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.
- Recall number
- Z-2200-2008
- 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.
- Status
- Terminated
- Initiated
- 2008-06-16
- Posted
- 2008-09-11
- Terminated
- 2011-06-23
- Reason
- Possibility of compromised package sterility prior to the expiration date.
- 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
- 300,000 units.
- Distribution
- Worldwide Distribution --- USA including states of CA, KS, MO, NC, NV, TX, VA, and WA and country of Japan.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K905563","K955443","K961424"]
- PMA numbers
- not on file
- Product code
- HFN
- Firm FEI
- 1718873
- Firm city
- Midvale
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28