Recall – Fluid control system displays incorrect deficit

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

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