Reported Oct 4, 2023 · Ongoing
Aquilex Fluid Control System-Intended to provide fluid distension of the uterus during diagnostic and operative…
WOM World Of Medicine AG
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: WOM World Of Medicine AG · Alte Poststr. 11 · Ludwigsstadt, N/A · N/A
Is this the product you have?
- Aquilex Fluid Control System-Intended to provide fluid distension of the uterus during diagnostic and operative hysteroscopies and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus. Models AQL-100PBS and AQL-100P
- Lot codes and dates
- UDI-DI04056702006914 Device Models
- AQL-100PBS and AQL-100P Serial NumbersUS
1,290 of 1,290 codes
S1802CE05381802CE05391802CE05401802CE05421802CE05431802CE05441802CE05451802CE05461802CE05471802CE06161802CE06171802CE06181802CE06191802CE06201802CE06211802CE06221802CE06241802CE06251802CE06481802CE06491802CE06511802CE06521802CE06531802CE06541802CE06551802CE06561802CE06571803CE01211803CE01221803CE01231803CE01241803CE01251803CE01261803CE01271803CE01281803CE01291803CE01301803CE01991803CE02011803CE02041803CE02051803CE02951803CE02961803CE02981803CE02991803CE03001803CE03011803CE03021803CE06631803CE09091803CE09101803CE09111803CE09121803CE09131803CE09141803CE09151803CE09161803CE09171803CE09181803CE0984
- Serial NumbersCanada
88 of 88 codes
1802CE06501803CE03021803CE06621803CE11281803CE11841804CE01361804CE01411804CE06181804CE06271804CE07531804CE07541804CE07561805CE00441805CE01751805CE02601805CE02651805CE05581805CE05591807CE02991807CE03541807CE03561807CE03581808CE11231808CE11271808CE11301808CE12291809CE02491809CE10581811CE07751811CE09001811CE09021811CE09041811CE09061902CE05951902CE05971902CE06341902CE07541902CE07561903CE05351903CE05631903CE07901904CE07521904CE07531904CE07551904CE07561904CE07571904CE08021904CE08051904CE08061904CE08071904CE08091904CE08101906CE03611906CE03621906CE03651906CE03661906CE07131906CE07171906CE07181906CE0755
- Amount recalled
- 1287 units
Where it was sold
- Nationwide
Why it was recalled
The display of inflow volume can reach its limit of 30,000 ml during long procdeure and the inflow volume display will freeze at the maximum value while the deficit will start counting backwards until 0 ml is reached and may result in fluid overload
This product could cause temporary or reversible health problems — stop using it.
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