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

FDA device recall Z-1910-2025 · posted 2025-06-05 · Open, Classified

Recall details

Recalling firm

Healthmark Industries Co., Inc.

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.

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

MNL

Quantity affected

193035 units

Distribution

US Nationwide and Internationally to countries of: Canada, Malaysia.

Date initiated

2025-05-02

Date posted

2025-06-05

Location

Fraser, MI