Medline Kits containing BD SureStep Foley Tray Systems: SKU/Description: CDS984076J GYN ROBOTIC DYNJG001004A LAVH MINOR
FDA device recall Z-2479-2025 · posted 2025-08-28 · Open, Classified
Recall details
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Reason for recall
- 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).
- Action taken
- Firm notified customers via email and first-class mail of the action. Medline Industries LP instructed customers to request stickers to over-label the affected convenience kits with a warning label indicating to remove the affected component and replace it with product from supply. No kits are to be returned.
- Root cause
- Error in labeling
- Status
- Open, Classified
- Product code
- FDE
- Quantity affected
- 4 ea
- Distribution
- Domestic distribution to FL and IL. No OUS distribution reported.
- Date initiated
- 2025-07-23
- Date posted
- 2025-08-28
- Location
- Northfield, IL
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