Z-1883-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 3, 2019
- Initiation Date
- May 21, 2019
- Termination Date
- October 7, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7 units
Product Description
Hancock II T510 Bioprosthesis, Mitral, REF T510C27 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.
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 Pattern
Worldwide distribution - US Nationwide distribution in the states of TN, NY, NJ, and countries of France, Italy, Libya, Poland, Spain.
Code Information
GTIN: 00643169027077 Serial Numbers: B654768, B694390, B818699, B887929, B896723, B896730, B914146