Non-sterile procedural trays labeled as MAJOR/MINOR, 3 per case
This recall is currently active, issued January 27, 2023. It was issued by Medline Industries, Lp - Northfield.
- Recall Initiated
- November 17, 2022
- Posted
- January 27, 2023
- Recall Number
- Z-1032-2023
- Quantity
- 160 cases (480 units)
- Firm Location
- Northfield, IL
- Official Source
- View on FDA website ↗
Reason for Recall
Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the outer foil layer causing a breach in the sterile packaging.
Distribution
US Nationwide distribution in the states of AR, MD, WA, WI.
Lot / Code Info
Item Number: DYNJ900416M, UDI/GTIN Case: 40195327031672, UDI/GTIN Each: 10195327031671, Lot Number: 22IBQ980
Root Cause
Device Design
Action Taken
Medline Industries, LP notified consignees via email and first-class mail on 11/21/2022. Consignees were instructed to over-label the sterile kits with a warning label indicating Warning To Avoid Injury, Please Handle Blades with Care . For the Non-Sterile kits, they are to over label the affected kits indicating to remove the blades and replace from a different sterile supply. No product is to be returned. Customers were also instructed to complete and return the response form.