Recall Z-2767-2019 ยท HIG Insufflator, Hysteroscopic
WOM World of Medicine AG
Aquilex Fluid Control System component: Bag deflector, REF AQL-100CBS Product Usage: Distends uterus with fluid during diagnostic and operative hysteroscopies.
| Date | Aug 14, 2019 |
| Status | Terminated |
| Reason | The deficit displayed by the pump can differ from the real deficit, leading potentially to patient risk. |
| Root cause | Nonconforming Material/Component |
| Action | On August 14, 2019, W.O.M. World of Medicine GmbH issued a Medical Device Recall notice to their customer (distributor). On September 5, 2019, Hologic issued Medical Device Recall notices to their customers via USPS priority mail with delivery confirmation. Customers were advised to take the following actions: 1) Perform a visual check of your Aquilex system looking for obvious damage to the bag deflector using the criteria identified within the customer notice. 2) If you do not notice any obvious damage using the criteria listed within the customer letter, and your unit passes the belo |
| Quantity | 322 units |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K172040 | Aquilex Fluid Control System AQL-100S W.O.M. World of Medicine GmbH, Feb 5, 2018 |