Z-1147-2013 Class II Terminated
FDA device recall Z-1147-2013 was initiated by Transonic Systems Inc on March 28, 2013 and is designated Class II. Reason for recall: Transonic Systems Inc. have received complaints of blood leakage involving the AV Loop Kit. The recall status is terminated (terminated March 5, 2014). Affected quantity: 195 units total (140 units Domestic, 55 units Foreign).
Recall Details
- Product Type
- Devices
- Report Date
- April 24, 2013
- Initiation Date
- March 28, 2013
- Termination Date
- March 5, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 195 units total (140 units Domestic, 55 units Foreign)
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.
Reason for Recall
Transonic Systems Inc. have received complaints of blood leakage involving the AV Loop Kit.
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.
Code Information
Lot numbers: 102810, 010311 and 111810.