DuraLife Autoclavable Double Swivel Elbow recall
DuraLife Autoclavable Double Swivel Elbow, REF 60-0010 (UltraSet Product Code 66-1991); Swivel Elbow with Suction Port for use with breathing circuits
Why was DuraLife Autoclavable Double Swivel Elbow recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- DuraLife Autoclavable Double Swivel Elbow, REF 60-0010 (UltraSet Product Code 66-1991); Swivel Elbow with Suction Port for use with breathing circuits
- Recalling firm
- Smiths Medical ASD Inc.
- Quantity
- 47007 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, New Zealand, and Hong Kong.
- Recall date
- May 24, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)