FDA Medical Device Recalls (openFDA)
Cardinal Health 200, LLC: Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 10Fr., REF SU130-402D
- Recall number
- Z-1736-2024
- Recalling firm
- Cardinal Health 200, LLC
- Product
- Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 10Fr., REF SU130-402D
- Status
- Open, Classified
- Initiated
- 2024-03-27
- Posted
- 2024-05-01
- Terminated
- not on file
- Reason
- Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing sterilization.
- Root cause
- Under Investigation by firm
- Action
- Cardinal Health issued an URGENT MEDICAL DEVICE PRODUCT RECALL notice to its consignees on 03/27/2024 via overnight mail. The notice explained the issue, potential hazard, and requested the following: Locate, segregate, and cease use of the affected product, disseminate the notice to those who handle the product. Distributors were directed to notify their customers. CONTACT the appropriate Customer Service group to arrange return of product and with questions related to this notification. Monday Friday between 8:00am - 5pm EST: " Hospital 800-964-5227 " Federal Government 800-444-1166 " Distributor 800-635-6021 " All Other Customers 888-444-5440 For questions related to this notification and/or acknowledgement form that are not adequately addressed in this letter, please contact the market action team at: GMB-FieldCorrectiveAction@cardinalhealth.com or call 800-292-9332.
- Quantity
- 2905 cases of 12
- Distribution
- Worldwide distribution - US Nationwide and the countries of Panama, Guatemala, Chile, Caribbean Island, Costa Rica.
- Lot, serial or model codes
- UDI/DI 50192253016428 (Case), 20192253016427 (Box), 10192253016420 (Each), Lot Numbers: 231251D2, 231252D2, 231253D2, 231254D2, 231255D2, 231256D2, 231151D2, 231152D2, 231153D2, 210751D2, 210752D2, 210753D2, 210754D2, 210755D2
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GBX
- Firm FEI
- 3001236905
- Firm city
- Waukegan
- 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