Recall Z-0823-2018
LifeCell Corporation, A Wholly Owned Subsidiary of Allergan PLC · initiated August 8, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
REVOLVE ADVANCED ADIPOSE SYSTEM, for aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body contouring.
Codes / lots: Lot Number/Expiration Dates: 1) 10565 & 10641 - 5/31/2017 2) 10651, 10658, 10626 & 10628 - 6/30/2017 3) 10642, 10630, 10643, 10629, 10631 - 7/31/2017 4) 10669, 10633, 10634 & 10635 - 8/31/2017 5) 10636 & 10637 - 9/30/2017 6) 10736, 10693, 10695 & 10694 -10/31/2017 7) 10698, 10699, 10696 & 10697 -11/30/2017 8) 10700, 10701 & 10702 - 12/31/2017 9) 10704, 10705, 10703 & 10799 -1/31/2018 10) 10706, 10708 & 10785 - 2/28/2018 11) 10791, 10792, 10786, 10787 & 10707 - 3/31/2018 12) 10838, 10793, 10795, 10794 & 10788 - 4/30/2018 13) 10789, 10840 & 10796 - 5/31/2018 14) 10841, 10709, 10825 & 10782 - 6/30/2018 15) 10826, 10827 & 10783 - 7/31/2018 16) 11222, 11224, 11234, 11235, 11223, 11225, 11089, 11246, 10790, 10830, 11208, 11210, 11214, 11215, 11209, 11217, 11211, 11216, 11212, 11213, 11226, 11229, 11227 &11228 - 8/31/2018 17) 11236, 11237, 11247, 11232, 11230, 11233, 11219, 11231, 11262 & 11085 - 9/30/2018 18) 11553, 11554, 11252, 11556, 11087, 11555, 11090, 11249, 11253, 3038912, 11254, 3038910 & 3097870 - 10/31/2018 19) 11250, 11251, 11325, 11324, 11560 & 3103907 - 11/30/2018 20) 11326, 11328, 11327, 11331, 11329, 11330, 11820, 11819, 11578, 11821, 11822 & 11579 -1/31/2019 21) 11256…
Reason for recall
Presence of bacterial endotoxins levels above the acceptable limit
FDA-determined cause: Material/Component Contamination
Action taken
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. Within this notice, customers were advised to continue use of the product. On June 14, 2017, a second notice was issued to customers informing customers that product shipments will resume by August 1, 2017 and that manufacturing process improvements will be implemented. 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: Actions to be taken 1. Immediately examine your inventory and quarantine all product subject to this recall. 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. Your notification to your customers may be enhanced by including a copy of this recall notification letter. 2. 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. 3. Mail the postage paid BRF immediately. To assure that we can account for all recalled product, it is imperative that you return the BRF. 4. When returning the recalled product, attach the prepaid FedEx Authorized Return shipping label to the outside of the return carton. Return the recalled product and completed Packing Slip to: GENCO Pharmaceutical Services (GPS), a subsidiary of FedEx Supply Chain 6101 North 64th Street, Milwaukee, WI 53218 For Product Returns: Contact Genco Pharmaceutical Services, a subsidiary of FedEx Supply Chain at: 1-877-319-8961 during the hours of 7 AM - 5 PM CST. For Adverse Events/Product Complaints: Contact LifeCell at 1-800-367-5737, during the hours of 9 AM - 5 PM EST or via Email: complaintfeedbackregistration@lifecell.com For Credit or
Details
- Recall number
- Z-0823-2018
- Initiated
- August 8, 2017
- Terminated
- September 7, 2018
- Product code
- MUU – System, Suction, Lipoplasty
- Quantity
- 25,798 units
- Distribution
- US Nationwide, Canada, Australia, Chile, Brazil, Israel, Japan New Zealand & Singapore
- Recalling firm
- LifeCell Corporation, A Wholly Owned Subsidiary of Allergan PLC, Branchburg, NJ