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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 Plus see related information
Date Initiated by Firm June 16, 2008
Date Posted September 11, 2008
Recall Status1 Terminated 3 on June 23, 2011
Recall Number Z-2200-2008
Recall Event ID 48679
510(K)Number K905563  K955443  K961424  
Product Classification Intrauterine Pressure Transducer - Product Code HFN
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.
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
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.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = HFN and Original Applicant = UTAH MEDICAL PRODUCTS, INC.
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