ChannelCheck Convenience Pack, Model Numbers UCC-222CP and UCC-222-ESP (Sample)
This recall is currently active, issued June 5, 2025. It was issued by Healthmark Industries Co., Inc..
- Company
- Healthmark Industries Co., Inc.
- Recall Initiated
- May 2, 2025
- Posted
- June 5, 2025
- Recall Number
- Z-1910-2025
- Quantity
- 193035 units
- Firm Location
- Fraser, MI
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
US Nationwide and Internationally to countries of: Canada, Malaysia.
Lot / Code Info
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
Root Cause
Under Investigation by firm
Action Taken
An "URGENT PRODUCT RECALL" notification letter was sent to customers beginning 5/2/25. Recommended Mitigations/ User Recommendations Please discontinue use of the Pre-Filled Water Syringes containing non-sterile water, which can be identified by a red cap. Any unused product can be returned for credit or replacement. Customer are requested to take the following actions 1. Ensure all affected product in your facility s inventory is no longer in use and has been properly quarantined. 2. Please ensure this message is forwarded to any individuals that need notification within your organization or any organization where the affected products have been transferred. 3. Contact Customer Service via email at HMCS@hmark.com or 800-521-6224 to return your unused affected product or if you have any questions. 4. Complete and return the response form Getinge by e-mailing a copy to recallresponses.qrc@getinge.com.