FDA Enforcement
Class II
Ongoing
STERILE PVP, REF DYNDA1649
Recall: Z-0528-2024
·
Reported December 20, 2023
Enforcement
- Recall Number
- Z-0528-2024
- 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, REF DYNDA1649
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 40889942326519 (case), 10889942326518 (each), Lot numbers: 2022060190, 2022021590
Distribution
US Nationwide distribution in the states of CT, IA, LA, MA, PA, CA, NY, FL.
Quantity
700 units