FDA Device recall Z-2767-2019
Aquilex Fluid Control System component: Bag deflector, REF AQL-100CBS Product Usage: Distends uterus with fluid during diagnostic and opera…
- FDA Device
- Class II
- terminated
- Published 2019-10-09
On 2019-10-09 the FDA classified a Class II recall of Aquilex Fluid Control System component: Bag deflector, REF AQL-100CBS Product Usage: Distends uterus with fluid during diagnostic and opera… by Wom World, citing the deficit displayed by the pump can differ from the real deficit, leading potentially to patient risk.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2767-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-08-14 |
| Published | 2019-10-09 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Wom World |
| Distribution | US |
Product
Aquilex Fluid Control System component: Bag deflector, REF AQL-100CBS Product Usage: Distends uterus with fluid during diagnostic and operative hysteroscopies.
Reason
The deficit displayed by the pump can differ from the real deficit, leading potentially to patient risk.
Identifiers
| code_info | UDI: 04056702006556 Serial Numbers: 1802CE0558 1803CE0226 1803CE0835 1804CE0075 1804CE0487 1804CE0912 1805CE…UDI: 04056702006556 Serial Numbers: 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 1804CE0495 1804CE0920 1805CE0600 1802CE0567 1803CE0235 1803CE0877 1804CE0212 1804CE0648 1805CE0031 1805CE0640 1803CE0024 1806CE0520 1803CE0878 1804CE0213 1804CE0649 1805CE0032 1805CE0641 1803CE0025 1803CE0498 1803CE0926 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2767-2019%22
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