Class 2 Device Recall Monoject Tuberculin Syringe

• Date Initiated by Firm: September 13, 2023
• Date Posted: October 13, 2023
• Recall Status: Open, Classified
• Recall Number: Z-0112-2024
• Recall Event ID: 93019
• 510(K)Number: K113091
• Product Classification: Syringe, piston - Product Code FMF
• Product: Monoject(TM) 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, Model Number/Product Code: 1180100777
• Code Information: Model Number/Product Code: 1180100777. UDI/DI: 10192253034530 each, 20192253034537 box, 50192253034538 case. 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: Todd King; 847-887-5500
• Manufacturer Reason for Recall: Syringe contains conical tip that is not compatible with certain needleless IV connector(s).
• FDA Determined Cause: Process change control
• Action: Cardinal Health notified consignees on about 09/13/2023 via letter titled "URGENT MEDICAL DEVICE PRODUCT CORRECTION." Customers were instructed to review inventory for the affected product code and lot, ensure all personnel are informed cease utilizing the affected product with needleless IV connectors, post a copy of the notification in the storeroom where the product is stored, and notify any customers if the product has been further distributed/forwarded. Additionally, customers were asked to complete and return the included acknowledgment form.
• Quantity in Commerce: 3.927,994 units
• Distribution: 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 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