WOM Aquilex Fluid Control System Bag Deflector Recalled for Pump Deficit Error
WOM World of Medicine AG is recalling Aquilex Fluid Control System bag deflectors because the pump's displayed deficit may differ from the actual deficit, posing a potential risk to patients.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the source text indicates a potential patient risk without reporting specific injuries or illnesses, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
WOM World of Medicine AG is recalling 322 units of the Aquilex Fluid Control System component, specifically the Bag deflector (REF AQL-100CBS). These components are used to distend the uterus with fluid during diagnostic and operative hysteroscopies. The recall covers units distributed nationwide in the United States.
The recall was initiated because the deficit displayed by the pump can differ from the real deficit. This discrepancy may lead to potential patient risk during the procedure. The source text does not report any specific injuries or illnesses associated with this defect.
Healthcare facilities and users should stop using the affected bag deflectors immediately. The recall is identified by FDA recall number Z-2767-2019. Specific serial numbers and the UDI (04056702006556) are listed in the official FDA record to identify the affected units.
The recalled product
- Product
- Aquilex Fluid Control System component: Bag deflector, REF AQL-100CBS Product Usage: Distends uterus with fluid during diagnostic and operative hysteroscopies.
- Manufacturer
- WOM World of Medicine AG
- Affected units
- 322
Distribution
Distributed nationwide across the United States.
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