FDA-Device2024-09-25Class II
Medline Contro-Bulb Syringe, REF DYND20125; bulb irrigation syringe
MEDLINE INDUSTRIES, LP - Northfield
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).
Sold states
US, Nationwide
Affected count
4831 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Medline Contro-Bulb Syringe, REF DYND20125; bulb irrigation syringe
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1157-2024Don't want to check this manually?
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