Medtronic Perfusion Systems Recalls Extra Corporeal Circuits Due to Sterilization Failure
Medtronic Perfusion Systems is recalling 10 extra corporeal circuits with bio-active surfaces because they failed a sterilization test. The units were distributed only to California and Michigan.
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 involves a medical device that failed a sterilization test, which poses a risk of harm (infection) even though no injuries or illnesses have been reported. This aligns with the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medtronic Perfusion Systems is recalling 10 units of extra corporeal circuits with bio-active surfaces. The recall was initiated because the affected products failed a sterilization test.
The recalled units, identified by Lot# 215729283, were distributed domestically only to California and Michigan. The source text does not specify the number of patients affected or report any illnesses or injuries associated with the use of these devices.
Consumers and healthcare facilities should stop using the affected units and contact Medtronic Perfusion Systems for further instructions on how to return or dispose of the products.
The recalled product
- Product
- Extra corporeal circuit with bio-active surface.
- Manufacturer
- Medtronic Perfusion Systems
- Affected units
- 10
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 (1)
- Lot# 215729283
Distribution
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