Medtronic BIO CAL Temperature Controller Recalled Due to Cleaning Protocol Issues
Medtronic is recalling BIO CAL Temperature Controllers because it cannot develop a cleaning protocol that meets current industry standards. Users are advised to discontinue use and dispose of the devices.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 used in critical surgical procedures where the inability to clean the device properly poses a risk of harm, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Medtronic Perfusion Systems is recalling 1,980 units of the BIO CAL Temperature Controller, Models 370 and 370I. These devices are thermal transfer modules designed to control patient blood temperature during cardiopulmonary bypass procedures. The units were distributed worldwide.
The recall is being issued because Medtronic has been unable to develop a cleaning protocol that satisfies current industry concerns and expectations. As a result, the company has determined that an updated cleaning protocol will not be developed. Medtronic has concluded that the best course of action is to request users to discontinue use and dispose of the BIO CAL devices.
Hospitals and healthcare facilities that have these devices should check their serial numbers against the list provided in the official recall notice. If a device is affected, it should be removed from service and disposed of according to the instructions provided by Medtronic.
The recalled product
- Product
- BIO CAL(R) Temperature Controller, Models: (a) 370, (b) 370I Product Usage: The BIO CAL(R) (unit) is a thermal transfer module designed to control patient blood temperature during cardiopulmonary bypass procedures when heating or cooling of the blood is desired.
- Manufacturer
- Medtronic Perfusion Systems
- Affected units
- 1,980
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)
- (a) Model 370
Distribution
Distribution scope not specified by the agency.
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