Reported Apr 24, 2013 · Terminated
HCS3011 AV Loop Kit For use with Transonic CO status System Only, -HCS3021 AV Loop Kit For use with Transonic CO status…
Transonic Systems Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Transonic Systems Inc · 34 Dutch Mill Rd · Ithaca, NY · 14850-9785
Is this the product you have?
- 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 Usageis 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
- Lot codes and dates
- Lot numbers
102810010311 and 111810
- Lot numbers
- Amount recalled
- 195 units total (140 units Domestic, 55 units Foreign)
Where it was sold
Why it was recalled
Transonic Systems Inc. have received complaints of blood leakage involving the AV Loop Kit.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Transonic Systems Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.