Smiths Medical Recalls Medex High Pressure Stopcocks Due to Leak Risk
Smiths Medical ASD Inc. is recalling specific lots of Medex High Pressure Stopcocks because an inner body defect may cause the device to leak.
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: The recall is classified as FDA Class II, and the hazard involves a potential leak in a medical device used for IV fluid flow, which poses a risk of harm without reported injuries.
Plain-English summary
Smiths Medical ASD Inc. is recalling certain lots of Medex High Pressure Stopcocks. These devices are used to control the direction of intravenous (IV) fluid flow and are intended for single use. The recall involves 2,425 devices.
The recall was initiated because the affected stopcocks were manufactured with an inner body defect that may result in a leak. The specific model and lot numbers involved are MX4301L (Lot 3538569), MX4331L (Lots 3562377 and 3546826), and MX4331R (Lot 3546924).
The potentially affected products were shipped to customers in the US, Canada, and Mexico. Healthcare facilities and distributors should check their inventory for these specific model and lot numbers and stop using the affected devices immediately.
The recalled product
- Product
- Medex High Pressure Stopcock used to control the direction of IV fluid flow. This device is intended for single use only and is provided sterile and fluid path non-pyrogenic unless package is damaged or opened.
- Manufacturer
- Smiths Medical ASD Inc.
- Hazard
- Affected units
- 2,425
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Model Number (Lot Number): MX4301L (3538569)
- MX4331L (3562377
- 3546826)
- MX4331R (3546924)
Distribution
Distribution scope not specified by the agency.
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