![]() ![]() US Nationwide, Canada, Australia, Chile, Brazil, Israel, Japan New Zealand & Singaporeġ A record in this database is created when a firm initiates a correction or removal action. GENCO Pharmaceutical Services (GPS), a subsidiary of FedEx Supply ChainĦ101 North 64th Street, Milwaukee, WI 53218įor Product Returns: Contact Genco Pharmaceutical Services, a subsidiary of FedEx Supply Chain at: 1-87 during the hours of 7 AM - 5 PM CST.įor Adverse Events/Product Complaints: Contact LifeCell at 1-80, during the hours of 9 AM - 5 PM EST or via Email: Credit or Return the recalled product and completed Packing When returning the recalled product, attach the prepaid FedEx Authorized Return shipping label to the outside of the return carton. To assure that we can account for all recalled product, it is imperative that you return the BRF.Ĥ. Carry out a physical count of the affected product in your possession and record the count on the enclosed postage paid Business Reply Form (BRF) and Packing slip.ģ. ![]() Your notification to your customers may be enhanced by including a copy of this recall notificationĢ. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall, and that all product should be quarantined. Immediately examine your inventory and quarantine all product subject to this recall. On August 8, 2017, Allergen distributed URGENT MEDICAL DEVICE RECALL notices and Business Reply Forms (dated August 2, 2017) to US customers advising them to take the following Actions:ġ. On June 14, 2017, a second notice was issued to customers informing customers that product shipments will resume by Augand that manufacturing process improvements will be implemented. Within this notice, customers were advised to continue use of the product. The firm's initial notice to customers (dated May 25, 2017) advising customers that Allergan has placed a hold on shipping the device until verification is complete. ![]() Presence of bacterial endotoxins levels above the acceptable limit LifeCell Corporation, A Wholly Owned Subsidiary of Allergan PLC REVOLVE ADVANCED ADIPOSE SYSTEM, for aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body contouring. ![]() System, suction, lipoplasty - Product Code MUU Class 2 Device Recall REVOLVE ADVANCED ADIPOSE SYSTEM ![]()
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