ChannelCheck Convenience Pack Pre-filled Water Syringes Recalled
Healthmark Industries is recalling ChannelCheck Convenience Pack Pre-filled Water Syringes (Models UCC-222CP and UCC-222-ESP) because contamination was found in duodenoscope samples linked to the syringes, which were improperly used outside their intended purpose.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II recall involving potential contamination in a medical device used in endoscopy procedures. The source text does not report any illnesses or injuries, but the hazard involves microbial contamination linked to duodenoscope samples, which presents a risk of harm even though no adverse health consequences have been reported yet, meeting the High criterion for risk-of-harm products without reported illness.
Plain-English summary
Healthmark Industries Co., Inc. is recalling ChannelCheck Convenience Pack Pre-filled Water Syringes, Model Numbers UCC-222CP and UCC-222-ESP (Sample). A user facility identified contamination in duodenoscope samples that were linked to these Pre-filled Water Syringes during endoscope surveillance monitoring.
Healthmark Industries conducted an investigation and concluded that the Pre-filled Water Syringes had been improperly used outside of their intended purpose. The recall affects approximately 193,035 units distributed nationwide in the United States and internationally to Canada and Malaysia.
Affected lot numbers include: 200014, 200015, 200016, 900153-900177, and 103564, 103312, 103293, 102807, 102096, 101673.
Users who have these syringes should discontinue use and contact Healthmark Industries for further instructions regarding the recalled product.
The recalled product
- Product
- ChannelCheck Convenience Pack, Model Numbers UCC-222CP and UCC-222-ESP (Sample)
- Manufacturer
- Healthmark Industries Co., Inc.
- Affected units
- 193,035
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Healthmark Industries Co., Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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