The Recall Desk
HighFDA (Devices)·Z-1480-2021·Announced 2021-04-28

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.

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 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.
Category
Medical Device — Cardiac / Pressure Monitoring
Hazard
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

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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.

See all 12 products in this recall →

Related recalls

Same manufacturer · Smiths Medical ASD Inc.

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Same hazard · structural defect

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