Z-1543-2013Class II

Deltran Disposable Pressure Transducer Kit (DPT Kit) Extracorporeal disposable pressure transducer and tubing...

Name: Z-1543-2013 Deltran Disposable Pressure Transducer Kit (DPT Kit) Extracorporeal disposable pressure transducer and tubing...
Creator: Utah Medical Products, Inc
Published: 2013-06-04
License: https://open.fda.gov/license/

Utah Medical Products, Inc / initiated 2013-06-04 / Terminated / root cause: packaging

FDA source

Utah Medical Products, Inc began a recall of Deltran Disposable Pressure Transducer Kit (DPT Kit) Extracorporeal disposable pressure transducer and tubing set with integral stopcock and flush device... on 2013-06-04. FDA classified it as Class II and gives the reason as "Utah Medical Products, Inc. is recalling certain Deltran Disposable Pressure Transducer Kits due to complaints related to packaging integrity of the sterile packaged devices". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1543-2013
Classification: Class II
Status: Terminated
Initiated: 2013-06-04
Posted: 2013-06-13
Terminated: 2013-09-19
Recalling firm: Utah Medical Products, Inc
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.
Product code: DRS Transducer, Blood-Pressure, Extravascular
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.
Root cause tag: packaging
FDA root cause: 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.
Product codes and lots: Part number DPT-248A, lot number 1122508.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1543-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1543-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-19	2013-06-13

Product code DRS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)