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Recall Observatory FDA recall evidence

Device 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.

Z-1543-2013

June 04, 2013

Class II

Product summary

Firm
Utah Medical Products, Inc
Event
Event 65374
Status
Terminated
Classification
Class II
Quantity
1,800 kits
Official record key
device-enforcement:Z-1543-2013

Official wording

Reason: Utah Medical Products, Inc. is recalling certain Deltran Disposable Pressure Transducer Kits due to complaints related to packaging integrity of the sterile packaged devices.

Code information: Part number DPT-248A, lot number 1122508.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Utah Medical Products, Inc. is recalling certain Deltran Disposable Pressure Transducer Kits due to complaints related to packaging integrity of the sterile packaged devices.