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
Reported: October 23, 2019 Initiated: September 12, 2019 #Z-0159-2020
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
Details
- Recalling Firm
- Olympus Corporation of the Americas
- Units Affected
- 1106 boxes (10 filters/box)
- Distribution
- US Nationwide distribution.
- Location
- Center Valley, PA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Olympus Corporation of the Americas. Units affected: 1106 boxes (10 filters/box).
Why was this product recalled? ▼
Berkeley Disposa-Filter may possess an insufficient ultrasonic weld defect which joins the two-halves of the filter cartridge, thus the housing could separate
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 23, 2019. Severity: Moderate. Recall number: Z-0159-2020.
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