Company: WOM World of Medicine AG
Date of Enforcement Report: 10/9/2019
Class II
PRODUCT
Aquilex Fluid Control System component: Bag deflector, REF AQL-100CBS Product Usage: Distends uterus with fluid during diagnostic and operative hysteroscopies.
- Recall Number: Z-2767-2019
REASON
The deficit displayed by the pump can differ from the real deficit, leading potentially to patient risk.
RECALLING FIRM/MANUFACTURER
WOM World of Medicine AG on 8/14/2019. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
322 units
DISTRIBUTION
US Nationwide