FDAFDA · Food and drugs·Recall number Z-1157-2024
Medline Contro-Bulb Syringe, REF DYND20125; bulb irrigation syringe
Published September 25, 2024 · Recall initiated: January 4, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Packaging material was updated for the Bulb Irrigation Syringe (DYND20125), and additional testing done at Medline Corporate indicated the potential for the sterile barrier to be breached during transportation. This only affects two lot numbers (96922110001 and 96923100001).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Distributor
- US, Nationwide
- Lot
- UDI/DI 40080196031765 (case), 10080196031764 (unit) Lot Numbers: 96922110001 and 96923100001
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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