Medtronic Venous Cannulae: a) DLP 20 Fr. Malleable Single Stage Venous Cannula, Model Number 68120, b) DLP 24 Fr. Mallea
FDA device recall Z-1805-2024 · 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
- 17221 units
- Distribution
- Worldwide distribution.
- Date initiated
- 2024-03-19
- Date posted
- 2024-05-10
- Location
- Brooklyn Park, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MALLEABLE SINGLE STAGE VENOUS CANNULA, MODELS 68112-68140 (15 TOTAL CODES) (K022272) | Medtronic Cardiac Surgical Products | 2003-01-08 |