FDA Medical Device Recalls (openFDA)
SPS Sterilization, Inc: Edwards Lifesciences EZ Glide Aortic Cannula, 24F x 37.6CM, resterilized.
- Recall number
- Z-3028-2018
- Recalling firm
- SPS Sterilization, Inc
- Product
- Edwards Lifesciences EZ Glide Aortic Cannula, 24F x 37.6CM, resterilized.
- Status
- Terminated
- Initiated
- 2018-03-07
- Posted
- not on file
- Terminated
- 2018-11-27
- Reason
- The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.
- Root cause
- Labeling False and Misleading
- Action
- Customers were notified via letter on about 03/02/2018. Instructions included to review inventory for affected devices, arrange for their return to SPS Sterilization, and complete and return the Buisness Response Card. A follow up letter was sent to customer on about 03/07/2018 and included a description of the risk and hazard involved. Instructions remained the same.
- Quantity
- 6 units total
- Distribution
- US distribution to AZ, CA, FL, OH, PA, TX, VA, WV
- Lot, serial or model codes
- Code Number EZC24A-R; Lot Number 59634962; Serial Numbers 16401032017-01, 16401032017-02, 16401032017-03, 16401032017-04, 16401032017-05, 16401032017-06, 16401032017-07, 16401032017-08, 16401032017-09, 16401032017-10, 16401032017-11, 16401032017-12, 16401032017-13, 16401032017-14, 16401032017-15, 16401032017-16, 16401032017-17, 16401032017-18, 16401032017-19, 16401032017-20, 16401032017-21, 16401032017-22, 16401032017-23, 16401032017-24, 16401032017-25, 16401032017-26, 16401032017-27, 16401032017-28, 16401032017-29, 16401032017-30, 16401032017-31, 16401032017-32, 16401032017-33, 16401032017-34, 16401032017-35, 16401032017-36, 16401032017-37
- 510(k) numbers
- ["K123370"]
- PMA numbers
- not on file
- Product code
- DWF
- Firm FEI
- 3005057969
- Firm city
- Nixa
- Firm state
- MO
- 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