Medtronic Arteriotomy Cannula Recall Due to Potential Unsealed Sterile Packing
Medtronic is recalling 7,935 units of I.M.A. Arteriotomy Cannula Model 31001 worldwide due to potential for unsealed sterile packing. Affected healthcare providers should verify lot numbers against inventory.
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: FDA Class II recall of a surgical device where the hazard—unsealed sterile packing—represents a risk-of-harm product where no injuries or illnesses have been reported. The potential sterility compromise meets the criteria for High severity under the rubric.
Plain-English summary
Medtronic Perfusion Systems is recalling the I.M.A. Cannulae DLP 1 mm Arteriotomy Cannula, Model Number 31001. A total of 7,935 units have been distributed worldwide.
The recall was initiated due to potential for unsealed sterile packing. This defect may compromise the sterility of the product. Affected lot numbers include 2023041320, 2023041323, 2023041316, 2023041318, and 202305C146, 202305C154 across multiple GTINs.
Healthcare providers and facilities using this product should verify lot numbers against their inventory and contact Medtronic Perfusion Systems for guidance on affected units. This is a Class II recall issued by the FDA.
The recalled product
- Product
- Medtronic I.M.A. Cannulae: DLP¿ 1 mm Arteriotomy Cannula, Model Number 31001
- Manufacturer
- Medtronic Perfusion Systems
- Hazard
- unsealed-sterile-pack
- contamination-risk
- infection-risk
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 (11)
- GTIN 00613994575319
- Lot Numbers: 2023041320
- 2023041323
- GTIN 00673978180465
- Lot Numbers: 2023041316
- GTIN 20613994575313
- Lot Numbers: 2023041316
- 2023041318
- 2023041320
- 202305C146
- 202305C154
Distribution
Distribution scope not specified by the agency.
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