Medline Contro-Bulb Syringe, REF DYND20125; bulb irrigation syringe
This recall is currently active, issued September 30, 2024. It was issued by Medline Industries, Lp - Northfield.
- Recall Initiated
- January 4, 2024
- Posted
- September 30, 2024
- Recall Number
- Z-1157-2024
- Quantity
- 4831 units
- Firm Location
- Northfield, IL
- Official Source
- View on FDA website ↗
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).
Distribution
US, Nationwide
Lot / Code Info
UDI/DI 40080196031765 (case), 10080196031764 (unit) Lot Numbers: 96922110001 and 96923100001
Root Cause
Under Investigation by firm
Action Taken
Medline Industries, LP issued an IMMEDIATE ACTION REQUIRED notice to its consignees on 01/04/2024 via USPS First Class. The notice explained the problem with the device, risk involved, and requested the consignee quarantine then destroy the affected product. Upon receipt of the completed destruction form, firm will issue credit, if applicable. Consignee was directed to notify all parties of this action to whom the product was distributed. For questions, contact 866-359-1704