Recall Z-1581-2023 ยท BZA Connector, Airway (Extension)
Smiths Medical ASD Inc.
DuraLife Autoclavable Silicone Extension Tube, REF 60-1502 (UltraSet Product Code 66-2509); Non-Ported Double Swivel Elbow for use with breathing circuits
| Date | May 12, 2023 (initiated Apr 5, 2023) |
| Status | Open, Classified |
| 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. |
| Root cause | Labeling False and Misleading |
| Action | Smiths Medical issued an URGENT MEDICAL DEVICE RECALL notice on 04/05/2023 by mail (traceable method). The notice explained the issue, potential risk, and request the following actions be taken: "Please discontinue the use and distribution of the affected product immediately. Check your inventory and quarantine all affected product at your facility. If you have expired product, do not use. 2) Inform potential users of the product in your organization of this notification and complete the attached response form. Return the completed response form to the fax number or e-mail address on the fo |
| Quantity | 2101 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, New Zealand, and Hong Kong. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.