Recall Z-2767-2019— WOM World of Medicine AG
Class II · Terminated
Class II FDA medical device recall by WOM World of Medicine AG, initiated 2019-08-14, terminated 2020-05-20. It names one FDA 510(k) clearance: K172040. Product: Aquilex Fluid Control System component: Bag deflector, REF AQL-100CBS Product Usage: Distends uterus with fluid during diagnostic and operative hysteroscopies.. Reason: The deficit displayed by the pump can differ from the real deficit, leading potentially to patient risk..
- Recalling firm
- WOM World of Medicine AG
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-08-14
- Terminated
- 2020-05-20
- Firm location
- Berlin, N/A, Germany
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Aquilex Fluid Control System component: Bag deflector, REF AQL-100CBS Product Usage: Distends uterus with fluid during diagnostic and operative hysteroscopies.
Reason for recall
The deficit displayed by the pump can differ from the real deficit, leading potentially to patient risk.
Data sourced from openFDA. This site is unofficial and independent of the FDA.