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U.S. Department of Health and Human Services

Class 2 Device Recall Intran Plus

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 Class 2 Device Recall Intran Plussee related information
Date Initiated by FirmJune 16, 2008
Date PostedSeptember 11, 2008
Recall Status1 Terminated 3 on June 23, 2011
Recall NumberZ-2200-2008
Recall Event ID 48679
510(K)NumberK905563 K955443 K961424 
Product Classification Intrauterine Pressure Transducer - Product Code HFN
ProductIntran 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.
Code Information 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.
Recalling Firm/
Manufacturer		 Utah Medical Products, Inc
7043 South 300 West
Midvale UT 84047
For Additional Information Contact
801-566-1200
Manufacturer Reason
for Recall		Possibility of compromised package sterility prior to the expiration date.
FDA Determined
Cause 2		Component change control
ActionAll 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 Commerce300,000 units.
DistributionWorldwide Distribution --- USA including states of CA, KS, MO, NC, NV, TX, VA, and WA and country of Japan.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = HFN
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