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.
Z-0616-2018
Product summary
- Firm
- AMEDA, INC.
- Event
- Event 78237
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 3,327 units total
- Official record key
device-enforcement:Z-0616-2018
Official wording
Reason: Two specific lots was incorrectly manufactured containing a UK power adapter.
Code information: Lot 7E058 and Lot 7E308
Distribution pattern: Distributed to CA, DC, DE, FL, GA, IL, MD, NC, NJ, OH, TX, UT, VA, and WA.
Derived failure modes
-
Unknown
Two specific lots was incorrectly manufactured containing a UK power adapter.