FDA Medical Device Recalls (openFDA)
Smiths Medical ASD Inc.: CADD Administration Sets, Model #21-7346-24
- Recall number
- Z-0148-2022
- Recalling firm
- Smiths Medical ASD Inc.
- Product
- CADD Administration Sets, Model #21-7346-24
- Status
- Terminated
- Initiated
- 2020-07-14
- Posted
- not on file
- Terminated
- 2023-08-04
- Reason
- Product may have been manufactured with an air filter assembled in an incorrect orientation.
- Root cause
- Process control
- Action
- The firm notified its consignees of the issue beginning on 07/14/2020. The firm requested the return of unused product. Distributors were directed to notify their customers. For questions contact Smiths Medical via email at fieldactions@smiths-medical.com.
- Quantity
- 371 units
- Distribution
- Canada
- Lot, serial or model codes
- Lot Numbers: 3750848, 3776357, 3793886, 3766764, 3793887, 3796141, 3776356, 3793888, 3847669
- 510(k) numbers
- ["K031361"]
- PMA numbers
- not on file
- Product code
- FPA
- 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