FDAClass IIJune 11, 2025

ChannelCheck Convenience Pack recall: Contamination

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

Why was ChannelCheck Convenience Pack 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.

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?

Lot Numbers: 200014 200015 200016 900153 900154 900155 900156 900157 900158 900159 900160 900161 900162 900163 900164 900165 900166 900167 900168 900169 900170 900171 900172 900173 900174 900175 900176 900177 103564 103312 103293 102807 102096 101673

Product
ChannelCheck Convenience Pack, Model Numbers UCC-222CP and UCC-222-ESP (Sample)
Recalling firm
Healthmark Industries Co., Inc.
Quantity
193035 units
Distribution
US Nationwide and Internationally to countries of: Canada, Malaysia.
Recall date
June 11, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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