FDA recall Z-1157-2024

Product

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).

Distribution

US, Nationwide

Key facts

Status

Ongoing

Initiation date

2024-01-04

Report date

2024-09-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1157-2024