DuraLife Autoclavable Double Swivel Elbow, REF 60-0010 (UltraSet Product Code 66-1991); Swivel Elbow with Suction Port for use with breathing circuits
- Company
- Smiths Medical Asd Inc.
- Recall Initiated
- April 5, 2023
- Posted
- May 12, 2023
- Recall Number
- Z-1580-2023
- Quantity
- 47007 units
- Firm Location
- Minneapolis, MN
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.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, New Zealand, and Hong Kong.
Lot / Code Info
Lot Numbers: 3577218, 3738865, 3887812, 4024574, 4151070, 4258733, 3582650, 3752126, 3901443, 4029610, 4153964, 4258734, 3587542, 3761923, 3911867, 4038968, 4164878, 4264897, 3596826, 3768558, 3914813, 4041942, 4173946, 4269655, 3604794, 3768559, 3917564, 4063257, 4176082, 4279829, 3613310, 3772121, 3931273, 4063258, 4182389, 4279830, 3623879, 3779557, 3933681, 4067165, 4187590, 4284606, 3627084, 3784957, 3936715, 4072088, 4192791, 4284607, 3643070, 3788286, 3942733, 4076804, 4201183, 4290269, 3671340, 3798095, 3952706, 4081672, 4204667, 4290270, 3671341, 3802450, 3956054, 4086259, 4215512, 4318561, 3673809, 3805780, 3959458, 4090323, 4219068, 4335149, 3687267, 3819513, 3970976, 4093610, 4229475, 4335150, 3690140, 3828396, 3974773, 4104647, 4242508, 4337436, 3700821, 3836009, 3988375, 4108513, 4242509, 4361916, 3709028, 3849849, 4001786, 4111190, 4247925, 3712265, 3863155, 4005980, 4116119, 4247926, 3723465, 3867378, 4011955, 4132044, 4254339, 3735446, 3880821, 4018725, 4138935, 4258732
Root Cause
Labeling False and Misleading
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."