—#205446

Product

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

FDA product code: KYZ — Syringe, Irrigating (Non Dental)
Device class: Class 1
Medical specialty: General Hospital
Affected lot / code info: UDI/DI 40080196031765 (case), 10080196031764 (unit) Lot Numbers: 96922110001 and 96923100001

Why it was 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).

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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

Recalling firm

Firm: MEDLINE INDUSTRIES, LP Northfield
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern: US, Nationwide

Timeline

Recall initiated: 2024-01-04
Posted by FDA: 2024-09-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #205446. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.