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Recall Observatory FDA recall evidence

Device product

Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010

Z-1909-2025

May 02, 2025

Class II

Product summary

Firm
Healthmark Industries Co., Inc.
Event
Event 96823
Status
Ongoing
Classification
Class II
Quantity
250000 units
Official record key
device-enforcement:Z-1909-2025

Official wording

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 information: Lot Numbers: 200001 200002 200003 200004 200005 200006 200007 200008 200009 200010 200011 200012 200013

Distribution pattern: US Nationwide and Internationally to countries of: Canada, Malaysia.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.