MEDLINE INDUSTRIES, LP Northfield Non-sterile procedural trays labeled as CRANI, 2 per case Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Non-sterile procedural trays labeled as CRANI, 2 per case
Brand
MEDLINE INDUSTRIES, LP Northfield
Lot Codes / Batch Numbers
Item Number: DYNJ900413P, UDI/GTIN Case: 40195327031665, UDI/GTIN Each: 40195327031665, Lot Number: 22JDB689
Products Sold
Item Number: DYNJ900413P, UDI/GTIN Case: 40195327031665, UDI/GTIN Each: 40195327031665, Lot Number: 22JDB689
MEDLINE INDUSTRIES, LP Northfield is recalling Non-sterile procedural trays labeled as CRANI, 2 per case due to Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the outer foil layer causing a breach in the sterile pack. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026