Monoject(TM) 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, Model Number/Product Code: 1180100777
FDA Recall Z-0112-2024 · Posted 2023-10-13
Recalling FirmCardinal Health 200, LLC
Recall StatusOpen, Classified
Product CodeFMF
Date Initiated2023-09-13
Product Quantity3.927,994 units
Reason for Recall
Syringe contains conical tip that is not compatible with certain needleless IV connector(s).
Firm 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.
Root Cause
Process change control
Distribution Pattern
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
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.