Z-0159-2020 Class II Ongoing
FDA device recall Z-0159-2020 was initiated by Olympus Corporation of the Americas on September 12, 2019 and is designated Class II. Reason for recall: Berkeley Disposa-Filter may possess an insufficient ultrasonic weld defect which joins the two-halves of the filter cartridge, thus the housing could separate The recall status is ongoing. Affected quantity: 1106 boxes (10 filters/box).
Recall Details
- Product Type
- Devices
- Report Date
- October 23, 2019
- Initiation Date
- September 12, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1106 boxes (10 filters/box)
Product Description
Berkeley Disposa-Filter used with Berkeley VC-10 Vacuum Curettage System - Product Usage: designed for rapid transcervical aspiration of the uterine cavity. Part# 54298-10/pack
Reason for Recall
Berkeley Disposa-Filter may possess an insufficient ultrasonic weld defect which joins the two-halves of the filter cartridge, thus the housing could separate
Distribution Pattern
US Nationwide distribution.
Code Information
Lot number: 494604