Z-0818-2019 Class II Terminated
FDA device recall Z-0818-2019 was initiated by Angiotech (Manan Medical Products, Inc.) on December 18, 2018 and is designated Class II. Reason for recall: Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line The recall status is terminated (terminated August 23, 2020). Affected quantity: 1,404 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 13, 2019
- Initiation Date
- December 18, 2018
- Termination Date
- August 23, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,404 units
Product Description
Aguja de Aspiracion con Profundidad Ajustable Tipo I 16ga x 5 cm- Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.
Reason for Recall
Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line
Distribution Pattern
Worldwide distribution - US Nationwide in the states of New Jersey, and countries of Mexico and South Korea.
Code Information
Model Number UCIN-16-5, Lot Number LK2L