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.
FDA Recall Z-1543-2013 · Posted 2013-06-13
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Recalling FirmUtah Medical Products, Inc
Recall StatusTerminated
Product CodeDRS
Date Initiated2013-06-04
Date Terminated2013-09-19
Product Quantity1,800 kits
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.
Firm 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.
Root Cause
Packaging
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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