STERILE PVP SOLUTION, REF DYNDA1907
FDA device recall Z-0525-2024 · posted 2023-12-11 · Open, Classified
Recall details
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Reason for recall
- 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.
- Action taken
- Medline Industries notified its consignees on 11/03/2023 via by email and US Mail (first class). The notice explained the issue and requested the destruction of any affected inventory. Distributor were directed to notify their customers.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- OFF
- Quantity affected
- 8250 units
- Distribution
- US Nationwide distribution in the states of CT, IA, LA, MA, PA, CA, NY, FL.
- Date initiated
- 2023-11-03
- Date posted
- 2023-12-11
- Location
- Northfield, IL
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