Smiths Medical Recalls Medfusion Syringe Infusion Pumps with Defective Barrel Clamp Guides
Smiths Medical ASD Inc. is recalling 276 Medfusion Syringe Infusion Pumps because a ridge in the Barrel Clamp Guide may cause spring slippage, preventing the pump from recognizing or correctly identifying loaded syringes.
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 risk-of-harm product (medical device) where the defect could lead to medication administration errors, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Smiths Medical ASD Inc. is recalling 276 units of the Medfusion Syringe Infusion Pump containing the Barrel Clamp Guide mechanism. The recall is due to a potential ridge in the Barrel Clamp Guide that could lead to spring slippage. This defect may result in the pump's inability to recognize a loaded syringe or the misidentification of the size of a loaded syringe.
The affected products are identified by Barrel Clamp Guide mechanism number G6000716 and lot numbers P0239588, P0321444, and P0462421. These units were distributed in the United States to Alabama, Arizona, California, the District of Columbia, Florida, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, Virginia, and Washington. International distribution included Canada and Lebanon.
Healthcare facilities and consumers should check their inventory for the specific mechanism and lot numbers listed above. If the affected units are found, they should be removed from service and the recalling firm contacted for instructions on return or replacement.
The recalled product
- Product
- Medfusion Syringe Infusion Pump, containing the Barrel Clamp Guide mechanism
- Manufacturer
- Smiths Medical ASD Inc.
- Category
- Medical Device — Infusion Pump
- Affected units
- 276
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)
- Barrel Clamp Guide mechanism number: G6000716
- Barrel Clamp Guide lot numbers: P0239588
- P0321444
- and P0462421
Distribution
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