Z-1157-2024 Class II Ongoing
FDA device recall Z-1157-2024 was initiated by MEDLINE INDUSTRIES, LP - Northfield on Jan 4, 2024 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 4831 units.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 25, 2024
- Initiation Date
- Jan 4, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4831 units
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).
Distribution Pattern
US, Nationwide
Code Information
UDI/DI 40080196031765 (case), 10080196031764 (unit) Lot Numbers: 96922110001 and 96923100001
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1157-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026