Z-1881-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 13, 2020
- Initiation Date
- April 7, 2020
- Termination Date
- November 5, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 4 Branch, Product Code: M00202175928P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
Reason for Recall
Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts
Distribution Pattern
Worldwide distribution - US Nationwide distribution and the countries of Dubai, Argentina, Austria, Belgium, Brazil, Japan, Canada, China, Germany, Spain, Finland, France, UK, Hongkong, Italy, Korea, Netherlands, Poland, Serbia, Sweden.
Code Information
Serial Numbers: 1136650764 1136649656 1138918524 1139377657 1143579436 1143599946 1147678079 1152754107 1158302730 1159727382 1159721538 1163859207 1166883762 1172730370 1177896586 1138937162 1141871928 1148785668 1152764001 1158785925 1159740547 1163841540 1168007426 1177892046