Recall Z-1580-2023— Smiths Medical ASD Inc.
Class II · Ongoing
Class II FDA medical device recall by Smiths Medical ASD Inc., initiated 2023-04-05. FDA's recall record names no specific 510(k) clearance for this event. Product: DuraLife Autoclavable Double Swivel Elbow, REF 60-0010 (UltraSet Product Code 66-1991); Swivel Elbow with Suction Port for use with breathing circuits. Reason: 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..
- Recalling firm
- Smiths Medical ASD Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-04-05
- Firm location
- Minneapolis, MN, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.