Class 1 Device Recall Cardinal Health Monoject

• Date Initiated by Firm: December 28, 2023
• Date Posted: February 02, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0851-2024
• Recall Event ID: 93676
• 510(K)Number: K113091
• Product Classification: Syringe, piston - Product Code FMF
• Product: Cardinal Health Monoject, 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, REF 1180100777
• Code Information: UDI/DI 50192253034538 (Case), 20192253034537 (Box), 10192253034530 (Each), Lot Numbers: 221201, 221202, 221203, 230201, 230202, 230203, 230204, 230205, 230601
• Recalling Firm/ Manufacturer: Cardinal Health 200, LLC; 3651 Birchwood Dr; Waukegan IL 60085-8337
• For Additional Information Contact: 847-887-5500
• Manufacturer Reason for Recall: Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.
• FDA Determined Cause: Process change control
• Action: Cardinal Health issued an URGENT MEDICAL DEVICE PRODUCT CORRECTION notice to its consignees on 12/28/2023 via FedEx. The notice explained the problem with the device, risk to patient, and requested the following actions be taken: 1. REVIEW your inventory for the affected product codes and lots. Location of product code and lot are shown in above listed table and below example labeling. 2. COMMUNICATE with all personnel that utilize the Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) that they should not be used with enteral syringe feeding pumps. 3. POST a copy of this notification in your storeroom and clinical areas where the product is stored. 4. NOTIFY any customers to whom you may have distributed/forwarded affected product to or will send the product on to about this medical device product correction and share a copy of this notice. 5. RETURN the enclosed acknowledgment form via fax to 614-652-9648 or email to GMB-FieldCorrectiveAction@cardinalhealth.com, whether you have affected product or not. CONTACT the appropriate Customer Service group with questions related to this notification. Monday Friday between 8:00am - 5pm EST: " Hospital 800-965-5227 " 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. A subsequent recall letter dated 2/2/2024 flagged URGENT MEDICAL DEVICE PRODUCT RECALL was issued informing the customer that the recall now involves all sizes of the Cardinal Health brand Monoject sterile Syringe Luer-Lock Soft Packs and Monoject sterile Enteral Syringes with the ENFit connection. This letter supersedes the previous communications. The letter explains the issue, risk to health, and lists the actions that are required. The actions were: 1. REVIEW your inventory for the
• Distribution: Distribution US nationwide, Canada, Australia, LATAM (including Mexico, Colombia and Brazil), Netherlands.
• Total Product Life Cycle: TPLC Device Report

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.

• 510(K) Database: 510(K)s with Product Code = FMF and Original Applicant = JIANGYIN CAINA TECHNOLOGY CO., LTD