Deltran Disposable Pressure Transducer Kit (DPT Kit) Extracorporeal disposable pressure transducer and tubing set with i

FDA device recall Z-1543-2013 · posted 2013-06-13 · Terminated

Recall details

Recalling firm

Utah Medical Products, Inc

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.

Action taken

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

Status

Terminated

Product code

DRS

Quantity affected

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

Date initiated

2013-06-04

Date posted

2013-06-13

Date terminated

2013-09-19

Location

Midvale, UT