PlainRecalls
FDA Devices Moderate Class II Ongoing

Medline Contro-Bulb Syringe, REF DYND20125; bulb irrigation syringe

Reported: September 25, 2024 Initiated: January 4, 2024 #Z-1157-2024

Product Description

Medline Contro-Bulb Syringe, REF DYND20125; bulb irrigation syringe

Reason for Recall

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).

Details

Units Affected
4831 units
Distribution
US, Nationwide
Location
Northfield, IL

Frequently Asked Questions

What product was recalled?
Medline Contro-Bulb Syringe, REF DYND20125; bulb irrigation syringe. Recalled by MEDLINE INDUSTRIES, LP - Northfield. Units affected: 4831 units.
Why was this product recalled?
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).
Which agency issued this recall?
This recall was issued by the FDA Devices on September 25, 2024. Severity: Moderate. Recall number: Z-1157-2024.