MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: OISC HAND BEAR, Model Number DYNJ902348L
This recall is currently active, issued July 12, 2023. It was issued by Medline Industries, Lp - Northfield.
- Recall Initiated
- May 18, 2023
- Posted
- July 12, 2023
- Recall Number
- Z-2134-2023
- Quantity
- 128 units
- Firm Location
- Northfield, IL
- Official Source
- View on FDA website ↗
Reason for Recall
Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING".
Distribution
Worldwide distribution - US Nationwide and the country of Panama.
Lot / Code Info
UDI/DI (EA) (01)10195327286057, UDI/DI(CS) (01)40195327286058; Lot Numbers: 23EDA775, 23CDB962
Root Cause
Process control
Action Taken
Medline issued a recall notice on 06/02/2023 to its consignees via USPS first class mail. The notice explained the problem with the product and requested the destruction of the product. Medline identified additional products, lots, and consignees and notified their consignees by email on 06/09/2023. Upon receipt of the submitted response form each account will receive over-labels to affix to the affected kits via FedEx overnight, if applicable. distributors were directed to notify their customers and collect the returned product and return it to Medline.