WOM World Of Medicine AG Recall 92938
Description: Aquilex Fluid Control System-Intended to provide fluid distension of the uterus during diagnostic and operative hysteroscopies and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus. Models AQL-100PBS and AQL-100P
WOM World Of Medicine AG Recall 92938 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2629-2023 |
| Event ID | 92938 |
| Event Description | Aquilex Fluid Control System-Intended to provide fluid distension of the uterus during diagnostic and operative hysteroscopies and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus. Models AQL-100PBS and AQL-100P |
| Product Type | Devices |
| Distribution | Nationwide Foreign: Canada, Australia, New Zealand, Belgium, France, Germany, Ireland, Netherlands, Spain, Sweden, Norway, Switzerland, UK, Kuwait, Qatar, Turkey, UAE |
| Quantity | 1287 units |
| Recall Reason | The display of inflow volume can reach its limit of 30,000 ml during long procdeure and the inflow volume display will freeze at the maximum value while the deficit will start counting backwards until 0 ml is reached and may result in fluid overload |
| Device Classification | 20231004 |
| Device Code Info | UDI-DI: 04056702006914 Device Models AQL-100PBS and AQL-100P Serial Numbers: US S1802CE0538 1802CE0539 1802CE0540 1802CE0542 1802CE0543 1802CE0544 1802CE0545 1802CE0546 1802CE0547 1802CE0616 1802CE0617 1802CE0618 1802CE0619 1802CE0620 1802CE0621 1802CE0622 1802CE0624 1802CE0625 1802CE0648 1802CE0649 1802CE0651 1802CE0652 1802CE0653 1802CE0654 1802CE0655 1802CE0656 1802CE0657 1803CE0121 1803CE0122 1803CE0123 1803CE0124 1803CE0125 1803CE0126 1803CE0127 1803CE0128 1803CE0129 1803CE0130 1803CE0199 1803CE0201 1803CE0204 1803CE0205 1803CE0295 1803CE0296 1803CE0298 1803CE0299 1803CE0300 1803CE0301 1803CE0302 1803CE0663 1803CE0909 1803CE0910 1803CE0911 1803CE0912 1803CE0913 1803CE0914 1803CE0915 1803CE0916 1803CE0917 1803CE0918 1803CE0984 1803CE0985 1803CE0986 1803CE0987 1803CE0988 1803CE0989 1803CE0990 1803CE0991 1803CE0992 1803CE1014 1803CE1015 1803CE1016 1803CE1017 1803CE1018 1803CE1019 1803CE1020 1803CE1021 1803CE1022 1803CE1023 1803CE1088 1803CE1089 1803CE1090 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| Center Classification Date | 20230922 |
| Recall Initiation Date | 20230717 |
| Recalling Firm | WOM World Of Medicine AG |
| Initial Notification | Letter |
| Similar To |