ChannelCheck Convenience Pack, Model Numbers UCC-222CP and UCC-222-ESP (Sample)
Recall
- Recall Number
- Z-1910-2025
- Event Number
- 96823
- Firm
- Healthmark Industries Co., Inc.
- FEI Number
- 1000160387
- Product Code
- MNL
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- May 2, 2025
- Posted
- June 5, 2025
- Address
- 18600 Malyn Blvd, Fraser, MI, 48026-3496
Description
ChannelCheck Convenience Pack, Model Numbers UCC-222CP and UCC-222-ESP (Sample)
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.
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 [email protected] 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 [email protected].
US Nationwide and Internationally to countries of: Canada, Malaysia.
193035 units