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MEDLINE INDUSTRIES, LP - Northfield recalls Medline Kits containing BD SureStep Foley Tray Systems: SKU/Description: CDS984076J GYN ROBOTIC DYNJG001004A LAVH
Recalled September 3, 2025 · FDA recall Z-2479-2025 · MEDLINE INDUSTRIES, LP - Northfield
Hazard
Kits contain SureStep Foley Tray Systems recalled by BD that include incorrect product information insert sheets. If a mislabeled tray is used, patient risk ranges from minor injury to injury that requires medical intervention, such as infection or local/systemic allergic reaction (anaphylaxis). · FDA Class II
Units
4 ea
Sold at
Domestic distribution to FL and IL. No OUS distribution reported.
Description
Kits contain SureStep Foley Tray Systems recalled by BD that include incorrect product information insert sheets. If a mislabeled tray is used, patient risk ranges from minor injury to injury that requires medical intervention, such as infection or local/systemic allergic reaction (anaphylaxis).
Product
Medline Kits containing BD SureStep Foley Tray Systems: SKU/Description: CDS984076J GYN ROBOTIC DYNJG001004A LAVH MINOR DYNJG901001B CRANIOTOMY DYNJ908819B KIT CRANIOTOMY (only units from SKU DYNJG001004A LAVH MINOR were distributed)
Manufacturer(s)
MEDLINE INDUSTRIES, LP - Northfield
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →