FDA Recalls DuraLife Silicone Breathing Tube Extension Over Sterilization Guidance
Smiths Medical ASD recalled 14,941 DuraLife silicone extension tubes worldwide due to incomplete sterilization instructions that could compromise patient safety.
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: This is a Class II FDA recall of a medical device used in critical breathing circuits. Inadequate sterilization instructions present a theoretical infection risk to patients. Per the severity rubric, recalls involving risk-of-harm medical devices without reported injuries score as High (3).
Plain-English summary
Smiths Medical ASD Inc. is recalling 14,941 DuraLife Autoclavable Silicone Extension Tubes (REF 60-1510) used in breathing circuits. The extension tube is a medical device used to connect breathing circuit components during anesthesia and respiratory care.
The recall was initiated because the device's Instructions for Use do not adequately specify the cleaning method, the duration of the autoclave sterilization cycle, or the maximum number of times the device can be reused on a single patient. Without complete sterilization guidance, healthcare facilities and providers may not be able to properly clean and sterilize the device before reuse, creating a potential infection risk.
The affected devices were distributed worldwide, including throughout the United States, Canada, New Zealand, and Hong Kong. Healthcare facilities and providers using these devices should review their cleaning and sterilization procedures and contact Smiths Medical ASD Inc. for clarification on proper device sterilization methods.
The recalled product
- Product
- DuraLife Autoclavable Silicone Extension Tube, REF 60-1510 (UltraSet Product Code 66-2505); Swivel Elbow with Suction Port for use with breathing circuits
- Manufacturer
- Smiths Medical ASD Inc.
- Hazard
- inadequate-sterilization
- infection-risk
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: 3572938
- 3709023
- 3917565
- 4081673
- 4176083
- 4258736
- 3582668
- 3735447
- 3936716
- 4090325
- 4176084
- 4272705
- 3602084
- 3784974
- 3974795
- 4100952
- 4187591
- 4272706
- 3617047
- 3812333
Distribution
Distributed nationwide across the United States.
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