Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1580-2023 — DuraLife Autoclavable Double Swivel Elbow, REF 60-0010 (UltraSet Product Code 66-1991); Swivel Elbow with Suction Port for use with breathing circuits

U.S. FDA — Device Enforcement · United States · 2023-04-05 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1580-2023
Date of alert
2023-04-05
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Smiths Medical ASD Inc.
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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