Jackson-Pratt 3-Spring Reservoir with Silicone Adapters, 400mL, REF SU130-475

FDA device recall Z-1739-2024 · posted 2024-05-01 · Open, Classified

Recall details

Recalling firm

Cardinal Health 200, LLC

Reason for recall

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.

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

GBX

Quantity affected

98 cases of 12

Distribution

Worldwide distribution - US Nationwide and the countries of Panama, Guatemala, Chile, Caribbean Island, Costa Rica.

Date initiated

2024-03-27

Date posted

2024-05-01

Location

Waukegan, IL