ChannelCheck Convenience Pack, Model Numbers UCC-222CP and UCC-222-ESP (Sample)
Reported: June 11, 2025 Initiated: May 2, 2025 #Z-1910-2025
Product Description
ChannelCheck Convenience Pack, Model Numbers UCC-222CP and UCC-222-ESP (Sample)
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.
Details
- Recalling Firm
- Healthmark Industries Co., Inc.
- Units Affected
- 193035 units
- Distribution
- US Nationwide and Internationally to countries of: Canada, Malaysia.
- Location
- Fraser, MI
Frequently Asked Questions
What product was recalled? ▼
ChannelCheck Convenience Pack, Model Numbers UCC-222CP and UCC-222-ESP (Sample). Recalled by Healthmark Industries Co., Inc.. Units affected: 193035 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 11, 2025. Severity: Moderate. Recall number: Z-1910-2025.
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