Aquilex Fluid Control System component: Bag deflector, REF AQL-100CBS Product Usage: Distends uterus with fluid during diagnostic and operative hysteroscopies.
Reported: October 9, 2019 Initiated: August 14, 2019 #Z-2767-2019
Product Description
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.
Details
- Recalling Firm
- WOM World of Medicine AG
- Units Affected
- 322 units
- Distribution
- US Nationwide Distribution
- Location
- Berlin, N/A
Frequently Asked Questions
What product was recalled? ▼
Aquilex Fluid Control System component: Bag deflector, REF AQL-100CBS Product Usage: Distends uterus with fluid during diagnostic and operative hysteroscopies.. Recalled by WOM World of Medicine AG. Units affected: 322 units.
Why was this product recalled? ▼
The deficit displayed by the pump can differ from the real deficit, leading potentially to patient risk.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 9, 2019. Severity: Moderate. Recall number: Z-2767-2019.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11