Recall Z-2767-2019
WOM World of Medicine AG · initiated August 14, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Aquilex Fluid Control System component: Bag deflector, REF AQL-100CBS Product Usage: Distends uterus with fluid during diagnostic and operative hysteroscopies.
Codes / lots: 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…
Reason for recall
The deficit displayed by the pump can differ from the real deficit, leading potentially to patient risk.
FDA-determined cause: Nonconforming Material/Component
Action taken
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 below mentioned Fluid Deficit Test you may continue to use your unit until you receive your replacement. 3) If you notice any damage or if any of the mentioned criteria are not met please stop using your Aquilex Fluid Control system. Customers with questions, please contact Hologic Technical Support at 1-855-898-5025. A Hologic representative will assist you with your return, as well as coordinate a replacement unit for you.
Details
- Recall number
- Z-2767-2019
- Initiated
- August 14, 2019
- Terminated
- May 20, 2020
- Product code
- HIG – Insufflator, Hysteroscopic
- Quantity
- 322 units
- Distribution
- US Nationwide Distribution
- Recalling firm
- WOM World of Medicine AG, Berlin