FDA Device recall Z-0525-2024
STERILE PVP SOLUTION, REF DYNDA1907
- FDA Device
- Class II
- ongoing
- Published 2023-12-20
On 2023-12-20 the FDA classified a Class II recall of STERILE PVP SOLUTION, REF DYNDA1907 by Medline Industries Northfield, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0525-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-11-03 |
| Published | 2023-12-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medline Industries Northfield |
| Distribution | US |
Product
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.
Identifiers
| code_info | UDI/DI 40889942574491 (case), 10889942574490 (each), Lot numbers: 22LBL675, 22JBR599, 22IBS045, 22GBT655, 22DBN398, 22…UDI/DI 40889942574491 (case), 10889942574490 (each), Lot numbers: 22LBL675, 22JBR599, 22IBS045, 22GBT655, 22DBN398, 22DBD250, 22DBA001, 21LBN032, 21JBA478, 21EBE405 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0525-2024%22
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