—#197453

Product

Cardinal Health Jackson-Pratt Channel Drain, 7 mm, REF JP-2210

FDA product code: GBX — Catheter, Irrigation
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: UDI/DI 50885380182479(cs), 20885380182478(ea), Lot Numbers: N210278, N210368, N210423, N210460, N210468 , N210543, N220050, N220099, N220139, N220163

Why it was recalled

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 (FDA determination)

Unknown/Undetermined by firm

Action the firm took

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.

Recalling firm

Firm: Cardinal Health 200, LLC
Address: 3651 Birchwood Dr, Waukegan, Illinois 60085-8337

Distribution

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia, Singapore, Hong Kong.

Timeline

Recall initiated: 2022-12-14
Posted by FDA: 2023-01-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #197453. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.