Medical device recalls Moderate risk

Healthmark Industries Co., Inc. recalls ChannelCheck Convenience Pack, Model Numbers UCC-222CP and UCC-222-ESP (Sample)

Recall date
May 2, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1910-2025
FDA classification
Class II
Brand / firm
Healthmark Industries Co., Inc.
Sold / distributed
US Nationwide and Internationally to countries of: Canada, Malaysia.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

ChannelCheck Convenience Pack, Model Numbers UCC-222CP and UCC-222-ESP (Sample)

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