FDAFDA · Food and drugs·Recall number Z-1147-2013
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.
Published April 24, 2013 · Recall initiated: March 28, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Transonic Systems Inc. have received complaints of blood leakage involving the AV Loop Kit.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Transonic Systems Inc
- Distributor
- 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.
- Lot
- Lot numbers: 102810, 010311 and 111810.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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