Medtronic EOPA Arterial Cannula, Model # 77620. Lot: 2015060544 intended to deliver oxygenated blood to the heart during cardiopulmonary bypass procedures for up to 6 hours in duration.
Recall
- Recall Number
- Z-2420-2015
- Event Number
- 71897
- Firm
- Medtronic Perfusion Systems
- FEI Number
- 1000116158
- Product Code
- DWF
- Status
- Terminated
- Root Cause
- Packaging process control
- Initiated
- July 24, 2015
- Posted
- August 19, 2015
- Terminated
- April 4, 2016
- Address
- 7611 Northland Dr N, Brooklyn Park, MN, 55428-1088
Description
Medtronic EOPA Arterial Cannula, Model # 77620. Lot: 2015060544 intended to deliver oxygenated blood to the heart during cardiopulmonary bypass procedures for up to 6 hours in duration.
EOPA Arterial Cannula Devices in this lot were shipped without the guidewire.
On July 24, 2015 Medtronic sales representatives began verbally notifying the customers of the issue, requesting quarantine and return of un-used, affected product Consignees were sent a Medtronic "Urgent Medical device Recall" letter dated August 2015. The letter was addressed to Risk Manger and Health Care Professional. The letter described the problem and the product involved in the recall. Advised consignees to quarantine and remove the product from their inventory and return it to Medtronic. Requested consignees to complete and return the Customer Confirmation Certificate via email to RS.CFQFCA@Medtronic com or fax to Medtronic 651-367-0612 to the attention of Customer Focused Quality. For questions contact your Medtronic Sales Representative or Lifeline Technical Services at 1-877-526-7890.
Worldwide distribution. US nationwide including: FL, GA, IL, MI, NY, NC, PA, WV; Germany, Hong Kong, and Italy.
221 (111 US, 110 OUS)