FDA Medical Device Recalls (openFDA)
Cardinal Health, Medical Products & Services: Presource PBDS, Total Hip, Kit, Circulator
- Recall number
- Z-1202-2013
- Recalling firm
- Cardinal Health, Medical Products & Services
- Product
- Presource PBDS, Total Hip, Kit, Circulator
- Status
- Terminated
- Initiated
- 2013-03-26
- Posted
- 2013-05-03
- Terminated
- 2017-04-12
- Reason
- Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow.
- Root cause
- Packaging process control
- Action
- Affected consignees were notified with a letter, dated March 26, 2013, sent via FedEx Priority, of this action. Cardinal Sales Representatives will also be advised and will verbally communicate the action to affected customers. The letter identified the affected product and the problem. Customers are to locate any affected product and quarantine them. In addition, clinicians should be informed of the issue; and, warning labels should be affixed to the front of each kit instructing users to remove and discard the Anesthesia Circuit and Filter Assembly. In order to confirm receipt of this action and completion of labeling the product, the enclosed Acknowledgement Form should be completed and returned to the number provided. If customers do now wish to accept overlabeled product or to overlabel the product in their possession, they are to contact Presource Sales Operations at 800-766-0706, or their sales representative for further instruction. Customers are to contact Cardinal Health Quality Systems at 800-292-9332, if they have any questions or need special assistance.
- Quantity
- 4,571 Kits total
- Distribution
- Distributed in the states of AR, MS, SC, and TN.
- Lot, serial or model codes
- Catalog Number: PO24THGWG01; Lots: 966051, 970753
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OFP
- Firm FEI
- 3001236905
- Firm city
- Park City
- Firm state
- IL
- 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