Pre-filled Water Syringe Recall due to Contamination from Improper Use
Healthmark Industries is recalling approximately 250,000 pre-filled water syringes (models SW-010-100 and SW-010) distributed nationwide and internationally after contamination was detected on endoscopic equipment traced to improper use of the syringes outside their intended purpose.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall involving contamination of endoscopic equipment. No illnesses or injuries have been reported, which limits the severity to High rather than Severe, per the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
Healthmark Industries Co., Inc. is recalling Pre-filled Water Syringes, Model Numbers SW-010-100 and SW-010. Approximately 250,000 units have been distributed nationwide in the United States, as well as internationally to Canada and Malaysia. The recall includes lot numbers 200001 through 200013.
During endoscope surveillance monitoring, a user facility identified contamination from duodenoscope samples that was linked to these pre-filled water syringes. Healthmark Industries conducted an investigation and concluded that the syringes had been improperly used outside of their intended purpose, which resulted in the contamination.
The recalled product
- Product
- Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010
- Manufacturer
- Healthmark Industries Co., Inc.
- Hazard
- contamination
Distribution
Distributed nationwide across the United States.
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