Device product

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

Z-1157-2024

January 04, 2024

Class II

Product summary

Firm: MEDLINE INDUSTRIES, LP - Northfield
Event: Event 93795
Status: Ongoing
Classification: Class II
Quantity: 4831 units
Official record key: device-enforcement:Z-1157-2024

Official wording

Reason: 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).

Code information: UDI/DI 40080196031765 (case), 10080196031764 (unit) Lot Numbers: 96922110001 and 96923100001

Distribution pattern: US, Nationwide

Derived failure modes

Sterility assurance
reason.sterility_assurance · v1.0.0

sterile barrier to be breached