FDA recall Z-2767-2019

Product

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.

Distribution

US Nationwide Distribution

Key facts

Status

Terminated

Initiation date

2019-08-14

Report date

2019-10-09

Termination date

2020-05-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Berlin, N/A, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2767-2019