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U.S. Department of Health and Human Services

Class 1 Device Recall Monoject Syringe

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 Class 1 Device Recall Monoject Syringesee related information
Date Initiated by FirmSeptember 20, 2023
Date PostedOctober 26, 2023
Recall Status1 Open3, Classified
Recall NumberZ-0148-2024
Recall Event ID 93075
510(K)NumberK113091 
Product Classification Syringe, piston - Product Code FMF
ProductMonoject 20 mL Syringe Luer-Lock Tip Soft Pack
Code Information Product Code: 1182000777; UDI/DI: 10192253034677 - each, 20192253034674 - box, 50192253034675 - case; Lot Numbers: 221201, 221202, 221203, 221204, 221205, 230201, 230202, 230203, 230204, 230205, 230206
Recalling Firm/
Manufacturer		 Cardinal Health 200, LLC
3651 Birchwood Dr
Waukegan IL 60085-8337
For Additional Information ContactTodd King
847-887-5500
Manufacturer Reason
for Recall		Demonstrated recognition and compatibility issues with syringe infusion pumps.
FDA Determined
Cause 2		Vendor change control
ActionCardinal Health notified customers on about 09/20/2023 via "URGENT MEDICAL DEVICE PRODUCT CORRECTION" letter sent FedEx next day delivery. Customers were instructed to: 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" Luer-Lock Tip syringes (1, 6, 12, 20, 35 and 60 mL) that they should not be used with syringe infusion pumps. 3. POST a copy of this notification in your storeroom 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. complete and return the provided acknowledgement form. 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 Commerce4,913,520 units
DistributionUS Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = FMF
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