Transonic AV Loop Kit Recalled for Blood Leakage Complaints
Transonic Systems Inc. is recalling HCS3011 and HCS3021 AV Loop Kits due to complaints of blood leakage. The kits are used for cardiovascular status assessment.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves blood leakage in a medical device, which poses a risk of harm even though specific injuries are not reported in the source text.
Plain-English summary
Transonic Systems Inc. is recalling the HCS3011 and HCS3021 AV Loop Kits. These products are 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. The recall involves 195 units total, with 140 units distributed domestically and 55 units distributed internationally.
The recall was initiated after the manufacturer received complaints of blood leakage involving the AV Loop Kit. The affected lot numbers are 102810, 010311, and 111810. Distribution was worldwide, including the United States and the Netherlands, Canada, and Russia.
Healthcare facilities and consumers should stop using the affected AV Loop Kits immediately. Users should contact Transonic Systems Inc. for further instructions on how to return or dispose of the product.
The recalled product
- 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 assessm
- Manufacturer
- Transonic Systems Inc
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot numbers: 102810
- 010311 and 111810.
Distribution
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