FDA-Device2025-09-03Class II
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)
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).
Sold states
Domestic distribution to FL and IL. No OUS distribution reported.
Affected count
4 ea
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
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)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2479-2025Don't want to check this manually?
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