Medline Surgical Kits Recalled for Incorrect Foley Tray Information
Medline surgical kits containing BD SureStep Foley Tray Systems have been recalled due to incorrect product information insert sheets that could lead to patient injury, including infection or allergic reaction.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving mislabeled medical device information that could result in improper use and patient harm, including risk of serious allergic reaction or infection. No illnesses or injuries have been reported to date, making this a risk-of-harm scenario without confirmed cases, warranting a High severity rating.
Plain-English summary
Medline surgical kits containing BD SureStep Foley Tray Systems have been recalled due to incorrect product information insert sheets. The affected kits include GYN ROBOTIC, LAVH MINOR, CRANIOTOMY, and KIT CRANIOTOMY models from Medline Industries, LP.
If a mislabeled tray is used during a medical procedure, patient risk ranges from minor injury to injury requiring medical intervention. Potential hazards include infection and allergic reactions, up to and including systemic allergic reaction (anaphylaxis).
The affected kits were distributed domestically to healthcare facilities in Florida and Illinois. Healthcare providers and facilities who received these kits should immediately remove them from use and contact Medline Industries or the FDA for return and disposal instructions.
The recalled product
- 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
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical Kits
- Hazard
- mislabeling
- allergic-reaction
- anaphylaxis
- infection
Distribution
Distributed in 2 states:
- FL
- IL
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