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U.S. Department of Health and Human Services

Class 2 Device Recall Deltran Kit

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 Class 2 Recall
Deltran Kit
see related information
Date Posted June 13, 2013
Recall Status1 Terminated on September 19, 2013
Recall Number Z-1543-2013
Recall Event ID 65374
Product Classification Transducer, Blood-Pressure, Extravascular - Product Code DRS
Product Deltran Disposable Pressure Transducer Kit (DPT Kit) Extracorporeal disposable pressure transducer and tubing set with integral stopcock and flush device, Product Usage: Deltran is a disposable pressure transducer that provides consistent and accurate readings during invasive blood pressure monitoring of humans and animals.
Code Information Part number DPT-248A, lot number 1122508.
Recalling Firm/
Manufacturer
Utah Medical Products, Inc
7043 South 300 West
Midvale, Utah 84047
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Ms. Marci Clawson
801-569-4101
Manufacturer Reason
for Recall
Utah Medical Products, Inc. is recalling certain Deltran Disposable Pressure Transducer Kits due to complaints related to packaging integrity of the sterile packaged devices.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Packaging
Action Utah Medical Products (UTMD) sent a Recall Notice letter dated June 3, 2013 via fax and email to all affected customers and will be completing follow up telephone calls by June 7, 2013. The letter identified the affected product, problem, health risk, and actions to be taken. UTMD instructed customers to locate and return affected products for exchange. For questions call Customer Service at 800-533-4984.
Quantity in Commerce 1,800 kits
Distribution Worldwide Distribution - United States Nationwide in the states of (MO, NE, KY, FL, OH, NY), and countries of Columbia, Brazil, Venezuela. West Indies, Latin America, Ecuador are distributed through a US direct consignee exporter.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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