Reported Oct 9, 2019 · Terminated

Aquilex Fluid Control System component: Bag deflector, REF AQL-100CBS Product Usage: Distends uterus with fluid during…

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 · Salzufer 8 · Berlin, N/A · N/A

Is this the product you have?

  • Aquilex Fluid Control System componentBag deflector
  • REF AQL-100CBS Product UsageDistends uterus with fluid during diagnostic and operative hysteroscopies
Lot codes and dates
  • UDI04056702006556
  • Serial Numbers

    508 of 508 codes

    • 1802CE0558
    • 1803CE0226
    • 1803CE0835
    • 1804CE0075
    • 1804CE0487
    • 1804CE0912
    • 1805CE0592
    • 1802CE0559
    • 1803CE0227
    • 1803CE0869
    • 1804CE0153
    • 1804CE0488
    • 1804CE0913
    • 1805CE0593
    • 1802CE0560
    • 1803CE0228
    • 1803CE0870
    • 1804CE0154
    • 1804CE0489
    • 1804CE0914
    • 1805CE0594
    • 1802CE0561
    • 1803CE0229
    • 1803CE0871
    • 1804CE0155
    • 1804CE0490
    • 1804CE0915
    • 1805CE0595
    • 1802CE0562
    • 1803CE0230
    • 1803CE0872
    • 1804CE0156
    • 1804CE0491
    • 1804CE0916
    • 1805CE0596
    • 1802CE0563
    • 1803CE0231
    • 1803CE0873
    • 1804CE0157
    • 1804CE0492
    • 1804CE0917
    • 1805CE0597
    • 1802CE0564
    • 1803CE0232
    • 1803CE0874
    • 1804CE0158
    • 1804CE0493
    • 1804CE0918
    • 1805CE0598
    • 1802CE0565
    • 1803CE0233
    • 1803CE0875
    • 1804CE0159
    • 1804CE0494
    • 1804CE0919
    • 1805CE0599
    • 1802CE0566
    • 1803CE0234
    • 1803CE0876
    • 1804CE0160
Amount recalled
322 units

Where it was sold

  • Nationwide

Why it was recalled

The deficit displayed by the pump can differ from the real deficit, leading potentially to patient risk.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated May 20, 2020 · Data as of Sep 19, 5:33 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.