WOM World of Medicine AG Salzufer 8 Berlin Germany Recalls
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Covidien HysteroLux Fluid Management System Control Unit, REF: 72205000
When the display of inflow volume to the uterus reaches 32450 ml, the fluid management system control unit display will freeze because the internal software calculation threshold is reached. The outflow measurement will continue, and so the deficit accumulated up to this point will start counting backwards to 0 ml. There is a risk of distention fluid reaching the soft tissue circulatory system.
On 06/18/21 a recall notice was emailed to their one distributor customer. This customer was informed that a new software version was created that would alert the user when an inflow volume of 28.000 ml is reached. This is designed to prepare the user for manual determination of the deficit. The recalling firm recommends updating the units with the new software version during the next preventive maintenance at the recalling firm's U.S. location with the following contacts to coordinate shipment: Katrin.Glushko@novanta.com, 1-407-438-8810; Robert.Almeida@novanta.com, 1-407-472-1509
PNEUMOCLEAR Heated High-Flow Tube Set Product Usage: The Heated High-Flow Tube Set is a single use sterile tube set used in combination with the PNEUMOCLEAR C02 insufflator as a separate accessory. The device PNEUMOCLEAR is a C02 insufflator intended for use during diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas. The Standard, High Flow/Bariatric, Pediatric and Advanced Flow operating mode of the device are indicated to fill and distend a periton
It is possible that the packaging of the product can be damaged by the prongs on the tube set.
WOM sent a Recall Notification letter dated October 22, 2018 to the their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to send all in the US recalled products back to: W.O.M. WORLD OF MEDICINE USA, Inc. 4531 36th Street Orlando, FL 32811-6527 WOM contacts for coordinating the shipment of the requested products to Orlando: Customer Service -W.O.M. Orlando Phone: +1 407 472 0372 Customer Service -W.O.M. Orlando Phone: +1 407 472 0371 Please send all recalled products returned to Stryker Venlo/Netherlands back to: W.O.M. WORLD OF MEDICINE GmbH Alte Poststr. 11 96337 Ludwigsstadt - Germany Customer Service: +49 30 39981 524
Aquilex Fluid Control System component: Bag deflector, REF AQL-100CBS Product Usage: Distends uterus with fluid during diagnostic and operative hysteroscopies.
The deficit displayed by the pump can differ from the real deficit, leading potentially to patient risk.
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.