Hancock II T510 Bioprosthesis, Mitral, REF T510C27 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.
- Company
- Medtronic Inc
- Recall Initiated
- May 21, 2019
- Posted
- June 26, 2019
- Terminated
- October 7, 2020
- Recall Number
- Z-1884-2019
- Quantity
- 1 unit
- Firm Location
- Minneapolis, MN
Reason for Recall
Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size. In all cases, the actual surgical heart valves are larger than what was indicated on the boxes and jar labels.
Distribution
Worldwide distribution - US Nationwide distribution in the states of TN, NY, NJ, and countries of France, Italy, Libya, Poland, Spain.
Lot / Code Info
GTIN: 00643169594425 Serial Number: B710405
Root Cause
Labeling mix-ups
Action Taken
The firm initiated the recall by telephone on 05/21/2019 and followed with a letter disseminated on 06/05/2019 which requested that the consignee quarantine any unused affected product and return it to Medtronic.