Date Initiated by Firm | May 21, 2019 |
Date Posted | June 26, 2019 |
Recall Status1 |
Terminated 3 on October 07, 2020 |
Recall Number | Z-1884-2019 |
Recall Event ID |
83038 |
PMA Number | P980043 |
Product Classification |
replacement Heart-valve - Product Code DYE
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Product | Hancock II T510 Bioprosthesis, Mitral, REF T510C27 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves. |
Code Information |
GTIN: 00643169594425 Serial Number: B710405 |
Recalling Firm/ Manufacturer |
Medtronic Inc 710 Medtronic Pkwy Mailstop Ls245 Minneapolis MN 55432-5603
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For Additional Information Contact | Joey Lomicky 763-526-2494 |
Manufacturer 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. |
FDA Determined Cause 2 | Labeling mix-ups |
Action | 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. |
Quantity in Commerce | 1 unit |
Distribution | Worldwide distribution - US Nationwide distribution in the states of TN, NY, NJ, and countries of France, Italy, Libya, Poland, Spain. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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PMA Database | PMAs with Product Code = DYE
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