Recall Z-1543-2013— Utah Medical Products, Inc

Class II · Terminated

Class II FDA medical device recall by Utah Medical Products, Inc, initiated 2013-06-04, terminated 2013-09-19. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..

Recalling firm
Utah Medical Products, Inc
Classification
Class II
Status
Terminated
Initiated
2013-06-04
Terminated
2013-09-19
Firm location
Midvale, UT, United States

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.