FDA Medical Device Recalls (openFDA)
Cardinal Health 200, LLC: Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2221
- Recall number
- Z-0981-2023
- Recalling firm
- Cardinal Health 200, LLC
- Product
- Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2221
- Status
- Open, Classified
- Initiated
- 2022-12-14
- Posted
- 2023-01-18
- Terminated
- not on file
- Reason
- Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of flexibility of wound drains, and broken wound tips.
- Root cause
- Unknown/Undetermined by firm
- Action
- Cardinal Health issued an URGENT MEDICAL DEVICE PRODUCT RECALL notice to its consignees on 12/14/2022 by overnight mail. The notice explained the issue, the risk, and requested the following: Actions Required: 1. REVIEW your inventory for the affected product codes and lots. Location of product codes and lots are shown above. 2. SEGREGATE and quarantine all affected product upon review of your inventory. Product should not be used and cease using the product immediately. 3. NOTIFY any customers to whom you may have distributed/forwarded affected product to or will send the product on to about this product recall notice and share a copy of this notice. 4. RETURN the enclosed acknowledgment form via fax to 614-652-9648 or email to GMBFieldCorrectiveAction@cardinalhealth.com, whether you have affected product. Return of Product and Available Assistance: CONTACT the appropriate Customer Service group to arrange for return and credit/replacement of any affected product 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
- 179 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia, Singapore, Hong Kong.
- Lot, serial or model codes
- UDI/DI 50885380182554(cs), 20885380182553(ea), Lot Numbers: N210278, N210368, N210423, N210460, N210468 , N210469, N210543, N220050, N220099, N220139, N220163
- 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