Medtronic EOPA Arterial Cannula, Model # 77620. Lot: 2015060544 intended to deliver oxygenated blood to the heart during
FDA device recall Z-2420-2015 · posted 2015-08-19 · Terminated
Recall details
- Recalling firm
- Medtronic Perfusion Systems
- Reason for recall
- EOPA Arterial Cannula Devices in this lot were shipped without the guidewire.
- Action taken
- 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.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- DWF
- Quantity affected
- 221 (111 US, 110 OUS)
- Distribution
- Worldwide distribution. US nationwide including: FL, GA, IL, MI, NY, NC, PA, WV; Germany, Hong Kong, and Italy.
- Date initiated
- 2015-07-24
- Date posted
- 2015-08-19
- Date terminated
- 2016-04-04
- Location
- Brooklyn Park, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA AND GUIDEWIRE (K031037) | Medtronic Perfusion Systems | 2003-05-13 |