FDA Medical Device Recalls (openFDA)
Smiths Medical ASD Inc.: DuraLife Autoclavable Silicone Extension Tube, REF 60-1510 (UltraSet Product Code 66-2505); Swivel Elbow with Suction Port for use with breathing circuits
- Recall number
- Z-1582-2023
- Recalling firm
- Smiths Medical ASD Inc.
- Product
- DuraLife Autoclavable Silicone Extension Tube, REF 60-1510 (UltraSet Product Code 66-2505); Swivel Elbow with Suction Port for use with breathing circuits
- Status
- Open, Classified
- Initiated
- 2023-04-05
- Posted
- 2023-05-12
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Labeling False and Misleading
- Action
- 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."
- Quantity
- 14941 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, New Zealand, and Hong Kong.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- BZA
- Firm FEI
- 3012307300
- Firm city
- Minneapolis
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28