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Class 2 Device Recall Cardinal Health JacksonPratt |
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Date Initiated by Firm |
March 27, 2024 |
Date Posted |
May 01, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1738-2024 |
Recall Event ID |
94309 |
Product Classification |
Catheter, irrigation - Product Code GBX
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Product |
Jackson-Pratt Universal Connector PVC Tubing Anti Reflux Transparent Y, REF SU130-4601 |
Code Information |
UDI/DI 50192253016459 (Case), 10192253016451 (Each), Lot Numbers: 210751D6 |
Recalling Firm/ Manufacturer |
Cardinal Health 200, LLC 3651 Birchwood Dr Waukegan IL 60085-8337
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For Additional Information Contact |
800-292-9332
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Manufacturer 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.
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FDA Determined Cause 2 |
Under Investigation by firm |
Action |
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. |
Quantity in Commerce |
64 cases of 6 |
Distribution |
Worldwide distribution - US Nationwide and the countries of Panama, Guatemala, Chile, Caribbean Island, Costa Rica. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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