DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)
- Company
- Medtronic Perfusion Systems
- Recall Initiated
- December 12, 2024
- Posted
- January 17, 2025
- Recall Number
- Z-0984-2025
- Quantity
- 745 units
- Firm Location
- Brooklyn Park, MN
Reason for Recall
Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
Distribution
Worldwide - US Nationwide distribution.
Lot / Code Info
Model 77008 UDI-DI: 20763000091105, Lot Numbers: 2024010723, 202404C049; Model 77014 UDI-DI: 20763000091136, Lot Number: 2023121097
Root Cause
Packaging
Action Taken
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 RS.CFQFCA@medtronic.com. 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.