EOPA Arterial Cannula, Model Numbers 77422 (22 Fr) and 77418 (18 Fr)
Recall
- Recall Number
- Z-0985-2025
- Event Number
- 96015
- Firm
- Medtronic Perfusion Systems
- FEI Number
- 1000116158
- Product Code
- DWF
- Status
- Open, Classified
- Root Cause
- Packaging
- Initiated
- December 12, 2024
- Posted
- January 17, 2025
- Address
- 7611 Northland Dr N, Brooklyn Park, MN, 55428-1088
Description
EOPA Arterial Cannula, Model Numbers 77422 (22 Fr) and 77418 (18 Fr)
Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
An URGENT: MEDICAL DEVICE RECALL notification letter dated 12/12/24 was sent to customers. Patient Recommendations: Patients previously supported with an impacted device face no additional risk from the issue described in this communication and should continue to be monitored per your practice s normal follow-up procedures. Customer Actions: Medtronic requests that you take the following actions: " Review your inventory for listed product. " Immediately identify and quarantine all unused, listed product in your inventory. " Return unused, listed product in your inventory to Medtronic by contacting Customer Service at 1-800-854-3570, Option 1 then Option 4, and referencing this communication to initiate a return and credit of unused product. Your Medtronic sales representative can assist you in the return of affected product as necessary. " Complete the enclosed Customer Confirmation Form and email to [email protected]. This form must be returned even if you do not have any affected product in your possession. " Please share this notification with others in your organization as appropriate. If product listed above has been forwarded to another facility, please notify the facility of this . " Please maintain a copy of this communication in your records. If you have any questions regarding this communication, please contact your Medtronic Field Representative.
Worldwide - US Nationwide distribution.
930 units