Aquilex Fluid Control System component: Bag deflector, REF AQL-100CBS Product Usage: Distends uterus with fluid during diagnostic and operative hysteroscopies.
Check against the official notice below — it lists the full affected range.
WOM World of Medicine AG is recalling 322 units of the Aquilex Fluid Control System bag deflector (REF AQL-100CBS) distributed nationwide in the United States. This device is used to distend the uterus with fluid during diagnostic and operative hysteroscopies. The recall was initiated because the fluid deficit displayed by the pump can differ from the actual deficit, which could potentially create a patient risk.
The affected units are identified by UDI 04056702006556 and specific serial numbers ranging from 1802CE0558 through 1805CE0649. The recall record does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
The deficit displayed by the pump can differ from the real deficit, leading potentially to patient risk.
Reason for recall: The deficit displayed by the pump can differ from the real deficit, leading potentially to patient risk. Distribution: US Nationwide Distribution Quantity: 322 units Lot/code info: 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 1804CE0214 1804CE0650 1805CE0033 1805CE0642 1803CE0026 1803CE0499 1803CE0927 1804CE0215 1804CE0651 1805CE0034 1805CE0643 1803CE0027 1803CE0500 1803CE0928 1804CE0216 1804CE0652 1805CE0035 1805CE0644 1803CE0028 1803CE0501 1803CE0929 1804CE0217 1804CE0653 1805CE0036 1805CE0645 1803CE0029 1803CE0502 1803CE0930 1804CE0218 1804CE0654 1805CE0037 1805CE0646 1803CE0030 1803CE0503 1803CE0931 1804CE0219 1804CE0655 1805CE0038 1805CE0647 1803CE0031 1803CE0504 1803CE0932 1804CE0220 1804CE0656 1805CE0039 1805CE0648 1803CE0032 1803CE0505 1803CE0933 1804CE0221 1804CE0657 1805CE0040 1805CE0649 1
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.