Medline Contro-Bulb Syringe recall: Sterility Concern
Medline Contro-Bulb Syringe, REF DYND20125; bulb irrigation syringe
Why was Medline Contro-Bulb Syringe 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).
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI/DI 40080196031765 (case), 10080196031764 (unit) Lot Numbers: 96922110001 and 96923100001
- Product
- Medline Contro-Bulb Syringe, REF DYND20125; bulb irrigation syringe
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 4831 units
- Distribution
- US, Nationwide
- Recall date
- September 25, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)