DuraLife Autoclavable Silicone Extension Tube, REF 60-1502 (UltraSet Product Code 66-2509); Non-Ported Double Swivel Elb

FDA device recall Z-1581-2023 · posted 2023-05-12 · Open, Classified

Recall details

Recalling firm

Smiths Medical ASD Inc.

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.

Action taken

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 form, even if you do not have the affected product. 3) Return affected product using the return label provided with this letter. Contact Sedgwick at 1-844-861-6220 (MF, 8am-5pm ET) if you have not received a return label or require additional labels for returning the affected product." "If you have distributed the product further, immediately notify your accounts that received the product identified in the Affected Product / Table 1 sections of this notification and ask them to contact Sedgwick at 1-844-861-6220 (M-F, 8am-5pm ET) to obtain a response form."

Root cause

Labeling False and Misleading

Status

Open, Classified

Product code

BZA

Quantity affected

2101 units

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, New Zealand, and Hong Kong.

Date initiated

2023-04-05

Date posted

2023-05-12

Location

Minneapolis, MN