Recall Z-2528-2018 ยท OMP Negative Pressure Wound Therapy Powered Suction Pump
Medela Inc
Invia Motion Negative Pressure Wound Therapy System. Labeled as: a. Endure Negative Pressure Wound Therapy (Model 087.4010); b. 15 Days Negative Pressure Wound Therapy (Model 087.4012); c. 60 Days Negative Pressure Wound Therapy (Model 087.4014); d. Endure Negative Pressure Wound Therapy (Model 087.4020 ); e. 15 Days Negative Pressure Wound Therapy (Model 087.4022); f. 60 Days Negati
| Date | Jul 23, 2018 (initiated Feb 7, 2018) |
| Status | Terminated |
| Reason | Device may display a battery missing error. |
| Root cause | Device Design |
| Action | Medela sent an Notification letter dated February 1, 2018 to customers via Certified Mail. The letter identified the affected product, problem and actions to be taken. Instructions included to place all affected items on hold until an insert outlining additional charging instructions were included with the devices. Those instructions included to provide a printed copy of the charging instructions in each device package, review those insert instructions with patients and care-givers, and complete and return the confirmation letter. For questions contact Medela Partner Services at info-healt |
| Quantity | 778 units |
| Distribution | US Nationwide Distribution domestically to AR, CA, FL, GA, IL, IN, LA, MI, MN, MO, NC, NJ, NY, OH, OK, PA, TX. Distributed internationally to Spain, Italy, Denmark, Sweden, Switzerland, Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K161128 | Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days Negative Pressure Wound Therapy Syst Medela AG, Dec 1, 2016 |