FDA Medical Device Recalls (openFDA)
Smiths Medical ASD Inc.: CADD High Volume Administration Set with FlowStop, 21-7381-24. Product Usage: The CADD High-Volume Administration set is designed for use with the CADD Prizm pump to allow fluid deliver from an IV bag.
- Recall number
- Z-2589-2017
- Recalling firm
- Smiths Medical ASD Inc.
- Product
- CADD High Volume Administration Set with FlowStop, 21-7381-24. Product Usage: The CADD High-Volume Administration set is designed for use with the CADD Prizm pump to allow fluid deliver from an IV bag.
- Status
- Terminated
- Initiated
- 2017-05-15
- Posted
- not on file
- Terminated
- 2018-04-04
- Reason
- One lot of CADD High Volume Administration sets, part number 21-7381-24, lot number 26X035, incorrectly contained the IFU insert for part number 21-7357-24.
- Root cause
- Process control
- Action
- Consignees were sent on 5/15/2017 a Smiths Medical "Urgent Medical device Recall Notice" dated May 15, 2017. The letter described the Affected Devices, Reason for Recall, Risk to Health, & Instructions to Customers. Advised consignees to complete and send the Urgent Medical Device Recall Response Form to smithsmedical7903@stericycle.com within 10 calendar days of receipt of this Notice.If you have distributed affected devices to your customers, immediately notify your customers of this Recall and retrieve all affected devices. For questions contact Stericycle via email at: smithsmedical7903@stericycle.com.
- Quantity
- 7,035
- Distribution
- US Nationwide in the states of PA, TN, NV, CA, MD, AR, CA, VA, OH, MN, NY, VT, NY.
- Lot, serial or model codes
- Lot#:26X035
- 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