DuraLife Autoclavable Double Swivel Elbow, REF 60-0010 (UltraSet Product Code 66-1991); Swivel Elbow with Suction Port for use with breathing circuits
Reported: May 24, 2023 Initiated: April 5, 2023 #Z-1580-2023
Product Description
DuraLife Autoclavable Double Swivel Elbow, REF 60-0010 (UltraSet Product Code 66-1991); Swivel Elbow with Suction Port for use with breathing circuits
Reason for Recall
DuraLife devices instructions for cleaning and sterilization have been determined to be inadequate. Specifically, for the DuraLife product, the IFU does not provide the cleaning method, duration of autoclave cycle or specify the number of cycles the product can be reused on a single patient.
Details
- Recalling Firm
- Smiths Medical ASD Inc.
- Units Affected
- 47007 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, New Zealand, and Hong Kong.
- Location
- Minneapolis, MN
Frequently Asked Questions
What product was recalled? ▼
DuraLife Autoclavable Double Swivel Elbow, REF 60-0010 (UltraSet Product Code 66-1991); Swivel Elbow with Suction Port for use with breathing circuits. Recalled by Smiths Medical ASD Inc.. Units affected: 47007 units.
Why was this product recalled? ▼
DuraLife devices instructions for cleaning and sterilization have been determined to be inadequate. Specifically, for the DuraLife product, the IFU does not provide the cleaning method, duration of autoclave cycle or specify the number of cycles the product can be reused on a single patient.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 24, 2023. Severity: Moderate. Recall number: Z-1580-2023.
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