Z-1909-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- June 11, 2025
- Initiation Date
- May 2, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 250000 units
Product Description
Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010
Reason for Recall
During endoscope surveillance monitoring, a user facility identified contamination from duodenoscope samples that were linked to the Pre-filled Water Syringes as part of their investigation. Healthmark Industries conducted its own investigation and concluded that the Pre-filled Water Syringe had been improperly used outside of the intended purpose.
Distribution Pattern
US Nationwide and Internationally to countries of: Canada, Malaysia.
Code Information
Lot Numbers: 200001 200002 200003 200004 200005 200006 200007 200008 200009 200010 200011 200012 200013