Recall Z-1157-2024— MEDLINE INDUSTRIES, LP - Northfield
Class II · Ongoing
Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2024-01-04. FDA's recall record names no specific 510(k) clearance for this event. Product: Medline Contro-Bulb Syringe, REF DYND20125; bulb irrigation syringe. 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)..
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-01-04
- Firm location
- Northfield, IL, United States
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.