Invia Motion Negative Pressure Wound Therapy System. Labeled as: a. Endure Negative Pressure Wound Therapy (Model 087.40
FDA device recall Z-2528-2018 · posted 2018-07-23 · Terminated
Recall details
- Recalling firm
- Medela Inc
- Reason for recall
- Device may display a battery missing error.
- Action taken
- 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-healthcare@medela.com or via phone 877-735-1626.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- OMP
- Quantity affected
- 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.
- Date initiated
- 2018-02-07
- Date posted
- 2018-07-23
- Date terminated
- 2018-12-04
- Location
- McHenry, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.