Recalls / —

—#203290

Product

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

FDA product code

FMF — Syringe, Piston

Device class

Class 2

Medical specialty

General Hospital

510(k) numbers

K113091

Affected 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.

Why it was recalled

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

Root cause (FDA determination)

Process change control

Action the firm took

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.

Recalling firm

Firm

Cardinal Health 200, LLC

Address

3651 Birchwood Dr, Waukegan, Illinois 60085-8337

Distribution

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

Timeline

Recall initiated

2023-09-13

Posted by FDA

2023-10-13

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #203290. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.