Transonic Systems Inc: Medical Device Recall in 2013 - (Recall #: Z-1147-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

HCS3011 AV Loop Kit For use with Transonic CO status System Only, -HCS3021 AV Loop Kit For use with Transonic CO status System Only. Product Usage: is indicated for use in patients greater than or equal to 2 years old with arterial and venous lines in the diagnostic assessment of cardiovascular status including cardiac output and associated hemodynamic parameters.

Product Classification:

Class II

Date Initiated: March 28, 2013

Date Posted: April 24, 2013

Recall Number: Z-1147-2013

Event ID: 64770

Reason for Recall:

Transonic Systems Inc. have received complaints of blood leakage involving the AV Loop Kit.

Status: Terminated

Product Quantity: 195 units total (140 units Domestic, 55 units Foreign)

Code Information:

Lot numbers: 102810, 010311 and 111810.

Distribution Pattern:

Worldwide Distribution - USA Nationwide including the states of AZ, CA, FL, GA, NM, NY, TX, VA and WA and countries of Netherlands, Canada and Russia.

Voluntary or Mandated:

Voluntary: Firm initiated