Medtronic DLP Vessel Cannula, Model Number REF 30000
FDA device recall Z-1316-2024 · posted 2024-03-19 · Open, Classified
Recall details
- Recalling firm
- Medtronic Perfusion Systems
- Reason for recall
- Medtronic is writing to inform you of incorrect labeling for three manufactured lots of the DLP Vessel Cannulae for the model and lot numbers listed above.
- Action taken
- Medtronic Cardiac Surgery issued an Urgent: Medical Device Recall to its consignees on 02/07/2024 via UPS. The notice explained the issue, potential risk, and requested consignees identify and quarantine affected product, and arrange to return the affected product by contacting customer service at 1-800-854-3570, option 1, then Option 4. The notification should be shared with others in your organization as appropriate. If product was forwarded to another facility, please notify the facility of this Medtronic Urgent Medical Device Recall.
- Root cause
- Packaging change control
- Status
- Open, Classified
- Product code
- DWF
- Quantity affected
- 4343 units
- Distribution
- US and Brazil, Canada, Republic of Georgia, Germany, India, Ireland, Italy, Malaysia, South Africa, UK
- Date initiated
- 2024-02-07
- Date posted
- 2024-03-19
- Location
- Brooklyn Park, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CARDIOPULMONARY BYPASS (K810820) | Dlp, Inc. | 1981-04-03 |