Recall Z-1147-2013— Transonic Systems Inc
Class II · Terminated
Class II FDA medical device recall by Transonic Systems Inc, initiated 2013-03-28, terminated 2014-03-05. It names one FDA 510(k) clearance: K080116. Product: 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: Transonic Systems Inc. have received complaints of blood leakage involving the AV Loop Kit..
- Recalling firm
- Transonic Systems Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-03-28
- Terminated
- 2014-03-05
- Firm location
- Ithaca, NY, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.