Monoject(TM) 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, Model Number/Product Code: 1180100777

FDA device recall Z-0112-2024 · posted 2023-10-13 · Open, Classified

Recall details

Recalling firm

Cardinal Health 200, LLC

Reason for recall

Syringe contains conical tip that is not compatible with certain needleless IV connector(s).

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.

Root cause

Process change control

Status

Open, Classified

Product code

FMF

Quantity affected

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, W

Date initiated

2023-09-13

Date posted

2023-10-13

Location

Waukegan, IL