Z-1882-2019 Class II Terminated
FDA device recall Z-1882-2019 was initiated by Medtronic Inc on May 21, 2019 and is designated Class II. 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 ja… The recall status is terminated (terminated October 7, 2020). Affected quantity: 5 units.
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
- 5 units
Product Description
Hancock II T510 Bioprosthesis, Mitral, REF T505U227 - 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: 00643169000261 Serial Numbers: B167637, B192698, B217347, B217329, B217330