FDA recall Z-2528-2018

Medela Inc · Class II · device

Product

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 Negative Pressure Wound Therapy (Model 087.4024). Product Usage: The Invia Motion Negative Pressure Wound Therapy (NPWT) system is indicated for patients who would benefit from a suction device (NPWT) as it creates an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material.

Reason for recall

Device may display a battery missing error.

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.

Key facts

Status
Terminated
Initiation date
2018-02-07
Report date
2018-08-01
Termination date
2018-12-04
Voluntary/Mandated
Voluntary: Firm initiated
Location
McHenry, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2528-2018