Smiths Medical Recalls Tubing Components Due to Incomplete Welds
Smiths Medical ASD Inc. is recalling specific lots of tubing components for blood-pressure transducers due to insufficient or incomplete welds.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 involves a medical device with a structural defect (incomplete welds) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Smiths Medical ASD Inc. is recalling specific lots of tubing with male luer lock adapters. These components are used in extravascular blood-pressure transducers and various cardiac kits, including pressure monitoring and interventional imaging devices.
The recall was initiated because the affected products may have been manufactured with insufficient or incomplete welds. The specific lots involved are REF 601280 (Lot Numbers 3872300, 3946984) and REF 601281 (Lot Numbers 3872301, 4024481). A total of 11,340 units are affected.
The products were distributed nationwide in the United States, including Puerto Rico, as well as in Austria, Canada, Chile, Ecuador, Hong Kong, Mexico, Slovenia, Brazil, South Africa, Colombia, and Japan. Users should check their inventory for these specific reference and lot numbers and stop using the affected components.
The recalled product
- Product
- Tubing with male luer lock adapter (Component) a. 76 cm, REF 601280 b. 122 cm, REF 607281. component of extravascular blood-pressure Transducer.
- Manufacturer
- Smiths Medical ASD Inc.
- Affected units
- 11,340
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 (5)
- a. REF 601280
- Lot Numbers: 3872300
- 3946984 b. REF 601281
- Lot Numbers: 3872301
- 4024481
Distribution
Part of a larger recall action
This product is one of 12 recalled by Smiths Medical ASD 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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