FDA Enforcement
Class II
Ongoing
Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010
Recall: Z-1909-2025
·
Reported June 11, 2025
Enforcement
- Recall Number
- Z-1909-2025
- Event ID
- 96823
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Healthmark Industries Co., Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 11, 2025
- Initiation Date
- May 2, 2025
- Classification Date
- June 5, 2025
- Address
- 18600 Malyn Blvd, N/A, Fraser, MI, 48026-3496, United States
Description
Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010
Reason
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.
Code Info
Lot Numbers: 200001 200002 200003 200004 200005 200006 200007 200008 200009 200010 200011 200012 200013
Distribution
US Nationwide and Internationally to countries of: Canada, Malaysia.
Quantity
250000 units