Pre-filled Water Syringe recalled for improper use contamination
Healthmark Industries is recalling Pre-filled Water Syringes (Model SW-010-100 and SW-010) after duodenoscope contamination was linked to improper use of the syringes outside their intended purpose.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall. The source text explicitly identifies the root cause as improper use outside intended purpose rather than a product defect, and there are no reports of patient illness or injury. The contamination was detected through surveillance monitoring, making this a precautionary recall related to user error rather than an inherent product hazard.
Plain-English summary
Healthmark Industries Co., Inc. is recalling Pre-filled Water Syringes, Model Numbers SW-010-100 and SW-010. During endoscope surveillance monitoring, a user facility identified contamination from duodenoscope samples that were linked to these syringes. Approximately 250,000 units have been distributed nationwide in the US and internationally to Canada and Malaysia.
The manufacturer conducted an investigation and determined that the Pre-filled Water Syringes had been improperly used outside of their intended purpose, which led to the contamination of duodenoscope samples. Healthcare facilities and users should verify they are using this product only as directed in its labeling and instructions for use to prevent similar contamination issues.
The recalled product
- Product
- Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010
- Manufacturer
- Healthmark Industries Co., Inc.
- Affected units
- 250,000
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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