FDA recall Z-0616-2018

AMEDA, INC. · Class III · device

Product

Purely Yours Breast Pump. Model 17070PMW and Model 17070ACA. Intended to express and collect the mother s milk from the breasts of a nursing woman for the purpose of feeding the collected milk to a baby.

Reason for recall

Two specific lots was incorrectly manufactured containing a UK power adapter.

Distribution

Distributed to CA, DC, DE, FL, GA, IL, MD, NC, NJ, OH, TX, UT, VA, and WA.

Key facts

Status
Ongoing
Initiation date
2017-07-10
Report date
2018-02-21
Voluntary/Mandated
Voluntary: Firm initiated
Location
Buffalo Grove, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0616-2018