—#206898

Product

Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 10Fr., REF SU130-402D

FDA product code: GBX — Catheter, Irrigation
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: UDI/DI 50192253016428 (Case), 20192253016427 (Box), 10192253016420 (Each), Lot Numbers: 231251D2, 231252D2, 231253D2, 231254D2, 231255D2, 231256D2, 231151D2, 231152D2, 231153D2, 210751D2, 210752D2, 210753D2, 210754D2, 210755D2

Why it was recalled

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 (FDA determination)

Under Investigation by firm

Action the firm took

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.

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 Panama, Guatemala, Chile, Caribbean Island, Costa Rica.

Timeline

Recall initiated: 2024-03-27
Posted by FDA: 2024-05-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #206898. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.