Medtronic Arterial Cannulae packaged as: a) DLP Curved Metal Tip Arterial Cannula 20 Fr., Model Number 80020; b) DLP Cur
FDA device recall Z-1793-2024 · posted 2024-05-10 · Open, Classified
Recall details
- Recalling firm
- Medtronic Perfusion Systems
- Reason for recall
- Potential for unsealed sterile packing.
- Action taken
- Medtronic issued an Urgent Medical Device Recall notice to its consignees on 03/19/2024 via letter (UPS). The notice explained the issue, potential risk, and requested the consignee identify and return the product. Consignee was directed to forward the notice to all affected parties. For questions, the consignee was directed to contact their Medtronic field representative.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- DWF
- Quantity affected
- 13033 units
- Distribution
- Worldwide distribution.
- Date initiated
- 2024-03-19
- Date posted
- 2024-05-10
- Location
- Brooklyn Park, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARTERIAL CANNULA CURVED BEVELED TIP (K840002) | Dlp, Inc. | 1984-02-13 |