Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2233

FDA device recall Z-0991-2023 · posted 2023-01-18 · Open, Classified

Recall details

Recalling firm

Cardinal Health 200, LLC

Reason for recall

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.

Action taken

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.

Root cause

Unknown/Undetermined by firm

Status

Open, Classified

Product code

GBX

Quantity affected

1920 units

Distribution

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

Date initiated

2022-12-14

Date posted

2023-01-18

Location

Waukegan, IL