Monoject(TM) 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, Model Number/Product Code: 1180100777
This recall is currently active, issued October 13, 2023. It was issued by Cardinal Health 200, Llc.
- Company
- Cardinal Health 200, Llc
- Recall Initiated
- September 13, 2023
- Posted
- October 13, 2023
- Recall Number
- Z-0112-2024
- Quantity
- 3.927,994 units
- Firm Location
- Waukegan, IL
- Official Source
- View on FDA website ↗
Reason for Recall
Syringe contains conical tip that is not compatible with certain needleless IV connector(s).
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
Lot / Code Info
Model Number/Product Code: 1180100777. UDI/DI: 10192253034530 each, 20192253034537 box, 50192253034538 case. Lot Numbers: 221201, 221202, 221203, 230201, 230202, 230203, 230204, 230205, 230601.
Root Cause
Process change control
Action Taken
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.