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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Smiths Medical ASD Inc.: 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.

Agency Publication Date: May 12, 2023
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Affected Products

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

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

Lot Numbers:
Numbers
Product: DuraLife Autoclavable Silicone Extension Tube, REF 60-1502 (UltraSet Product Code 66-2509); Non-Ported Double Swivel Elbow for use with breathing circuits

3569291, 3802463, 3974741, 4093611, 4219069, 4340640, 3582651, 3832622, 4001787, 4108514, 4242510, 4340642, 3609721, 3871182, 4011956, 4116120, 4254340, 3609743, 3891814, 4032896, 4122394, 4264898, 3693349, 3914797, 4041943, 4151071, 4279831, 3723464, 3927549, 4063256, 4167796, 4290272, 3761125, 3952707, 4090324, 4182390, 4340638

Product: DuraLife Autoclavable Silicone Extension Tube, REF 60-1510 (UltraSet Product Code 66-2505); Swivel Elbow with Suction Port for use with breathing circuits

Lot Numbers: 3572938, 3709023, 3917565, 4081673, 4176083, 4258736, 3582668, 3735447, 3936716, 4090325, 4176084, 4272705, 3602084, 3784974, 3974795, 4100952, 4187591, 4272706, 3617047, 3812333, 4011957, 4104648, 4207974, 4284609, 3623883, 3828394, 4029611, 4119019, 4207975, 4290273, 3631678, 3836006, 4038969, 4138936, 4220676, 4333910, 3662331, 3874536, 4063254, 4148601, 4242511, 4340649, 3688907, 3884430, 4067164, 4160298, 4254341, 4348704, 3693346, 3904854, 4076803, 4167797, 4258735

Lot Numbers:
Numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 91975
Status: Active
Manufacturer: Smiths Medical ASD Inc.
Manufactured In: United States
Units Affected: 3 products (47007 units; 2101 units; 14941 units)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.