FDA Medical Device Recalls (openFDA)
Cardinal Health Inc.: Presource Kit Total Joint Pack containing a double-wrapped basin component. Product Usage: This kit is used on patients undergoing joint replacement knee or hip.
- Recall number
- Z-0702-2019
- Recalling firm
- Cardinal Health Inc.
- Product
- Presource Kit Total Joint Pack containing a double-wrapped basin component. Product Usage: This kit is used on patients undergoing joint replacement knee or hip.
- Status
- Terminated
- Initiated
- 2018-11-16
- Posted
- not on file
- Terminated
- 2019-11-04
- Reason
- The double wrapping of this custom kit basin set is not supported by the current sterility assurance validation.
- Root cause
- Unknown/Undetermined by firm
- Action
- As only one customer is potentially impacted, in the interest of prompt action and notification, a teleconference was held on Friday, November 16, 2018 with the customer to communicate the impending actions. During this teleconference, the customer was informed that an HHE and field corrective action was in-process and that a study was being initiated to determine that their requested packaging configuration was acceptable. The customer also was informed that they should not continue to use the impacted double wrapped basin, and the components contained within, until the study was completed. Cardinal Health is following up on this teleconference with a written notification.
- Quantity
- 182 packs
- Distribution
- US state of Florida
- Lot, serial or model codes
- Product code: SOP22TJCLK Lot numbers # 104405, 122793, and 987948
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LRO
- Firm FEI
- 3007329020
- Firm city
- Dublin
- Firm state
- OH
- 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