Medtronic DLP Coronary Ostial Cannulae recalled for potential unsealed sterile packing
Medtronic recalled 250 units of DLP Coronary Ostial Cannulae (Model 30050) due to potential unsealed sterile packing. Lot 2023070529 was distributed worldwide.
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: This is an FDA Class II recall involving surgical instruments with potential sterility compromise. The hazard—unsealed sterile packing—creates a risk of infection during surgical use. No illnesses or injuries have been reported, meeting the criterion for High severity: a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Medtronic Perfusion Systems is recalling the DLP Coronary Ostial Cannulae, Model Number 30050. These surgical instruments are used in cardiac bypass procedures. The recall affects 250 units with lot number 2023070529 that were distributed worldwide.
The hazard identified is potential for unsealed sterile packing. Sterile surgical instruments must be maintained in sealed, sterile packaging to prevent contamination. If the sterile packing is not properly sealed, the instruments may become contaminated and could pose an infection risk if used in patients.
The recalled product
- Product
- Medtronic DLP Coronary Ostial Cannulae, Model Number 30050
- Manufacturer
- Medtronic Perfusion Systems
- Hazard
- unsealed-sterile-packaging
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 (3)
- GTIN 00613994576019
- Lot Numbers: 2023070529
- GTIN 20613994576013
Distribution
Distribution scope not specified by the agency.
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