FDA Recall Open, Classified

Medtronic DLP Vessel Cannula, Model Number REF 30000

Recall: Z-1316-2024 · Initiated February 7, 2024

Recall

Recall Number
Z-1316-2024
Event Number
94068
Firm
Medtronic Perfusion Systems
FEI Number
1000116158
Product Code
DWF
Status
Open, Classified
Root Cause
Packaging change control
Initiated
February 7, 2024
Posted
March 19, 2024
Address
7611 Northland Dr N, Brooklyn Park, MN, 55428-1088

Description

Medtronic DLP Vessel Cannula, Model Number REF 30000

Reason

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

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.

Distribution

US and Brazil, Canada, Republic of Georgia, Germany, India, Ireland, Italy, Malaysia, South Africa, UK

Quantity

4343 units