FDA Enforcement
Class II
Ongoing
STERILE PVP SOLUTION, REF DYNDA1907
Recall: Z-0525-2024
·
Reported December 20, 2023
Enforcement
- Recall Number
- Z-0525-2024
- Event ID
- 93395
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- MEDLINE INDUSTRIES, LP - Northfield
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- December 20, 2023
- Initiation Date
- November 3, 2023
- Classification Date
- December 11, 2023
- Address
- 3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States
Description
STERILE PVP SOLUTION, REF DYNDA1907
Reason
The product description on the labeling includes the word "Sterile" or STRL", however the contents of the solution inside the foil sachet is non-sterile.
Code Info
UDI/DI 40889942574491 (case), 10889942574490 (each), Lot numbers: 22LBL675, 22JBR599, 22IBS045, 22GBT655, 22DBN398, 22DBD250, 22DBA001, 21LBN032, 21JBA478, 21EBE405
Distribution
US Nationwide distribution in the states of CT, IA, LA, MA, PA, CA, NY, FL.
Quantity
8250 units