The Recall Desk
HighFDA (Devices)·Z-1580-2023·Announced 2023-05-24

Breathing circuit swivel elbow recalled for inadequate sterilization instructions

Smiths Medical is recalling DuraLife Swivel Elbow breathing circuit devices due to inadequate sterilization instructions. The device instructions lack cleaning methods, autoclave cycle duration, and reuse specifications.

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: FDA Class II medical device with inadequate sterilization and reuse instructions for a breathing circuit component. While no illnesses or injuries have been reported, inadequate sterilization guidance for reusable respiratory equipment presents a potential risk of improper device preparation and infection.

Plain-English summary

Smiths Medical ASD Inc. is recalling DuraLife Autoclavable Double Swivel Elbow devices (47,007 units) due to inadequate instructions for use. The product is designed for use with breathing circuits and has been distributed in the US, Canada, New Zealand, and Hong Kong.

The device's instructions for use do not provide cleaning methods, autoclave cycle duration, or specify the number of cycles the product can be reused on a single patient. Without proper sterilization and reuse guidance, devices may not be adequately prepared or may be used beyond safe limits.

Affected healthcare facilities should immediately contact Smiths Medical ASD Inc. for updated sterilization and reuse instructions before continuing to use these devices.

The recalled product

Product
DuraLife Autoclavable Double Swivel Elbow, REF 60-0010 (UltraSet Product Code 66-1991); Swivel Elbow with Suction Port for use with breathing circuits
Manufacturer
Smiths Medical ASD Inc.
Category
Medical Device — Breathing Circuit
Hazard
Affected units
47,007

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 (20)

  • Lot Numbers: 3577218
  • 3738865
  • 3887812
  • 4024574
  • 4151070
  • 4258733
  • 3582650
  • 3752126
  • 3901443
  • 4029610
  • 4153964
  • 4258734
  • 3587542
  • 3761923
  • 3911867
  • 4038968
  • 4164878
  • 4264897
  • 3596826
  • 3768558

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

Related recalls

Same manufacturer · Smiths Medical ASD Inc.

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Same hazard · sterilization defect

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