DuraLife Autoclavable Silicone Extension Tube, REF 60-1510 (UltraSet Product Code 66-2505); Swivel Elbow with Suction Port for use with breathing circuits
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
DuraLife Autoclavable Silicone Extension Tube, REF 60-1510 (UltraSet Product Code 66-2505); Swivel Elbow with Suction Port for use with breathing circuits
Product Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1582-2023
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