Recalls / —

—#203388

Product

Monoject" 35 mL Syringe Luer-Lock Tip Soft Pack

FDA product code

FMF — Syringe, Piston

Device class

Class 2

Medical specialty

General Hospital

510(k) numbers

K113091

Affected lot / code info

Product Code: 1183500777; UDI/DI: 10192253034691 - each, 20192253034698 - box, 50192253034699 - case; Lot Numbers: 221201, 230201, 230601, 230602

Why it was recalled

Demonstrated recognition and compatibility issues with syringe infusion pumps.

Root cause (FDA determination)

Vendor change control

Action the firm took

Cardinal Health notified customers on about 09/20/2023 via "URGENT MEDICAL DEVICE PRODUCT CORRECTION" letter sent FedEx next day delivery. Customers were instructed to: 1. REVIEW your inventory for the affected product codes and lots. Location of product code and lot are shown in above listed table and below example labeling. 2. COMMUNICATE with all personnel that utilize the Cardinal Health Monoject" Luer-Lock Tip syringes (1, 6, 12, 20, 35 and 60 mL) that they should not be used with syringe infusion pumps. 3. POST a copy of this notification in your storeroom where the product is stored. 4. NOTIFY any customers to whom you may have distributed/forwarded affected product to or will send the product on to about this medical device product correction and share a copy of this notice. 5. RETURN the enclosed acknowledgment form via fax to 614-652-9648 or email to GMB FieldCorrectiveAction@cardinalhealth.com, whether you have affected product or not. complete and return the provided acknowledgement form. For questions related to this notification and/or acknowledgement form that are not adequately addressed in this letter, please contact the market action team at: GMB-FieldCorrectiveAction@cardinalhealth.com or call 800-292-9332.

Recalling firm

Firm

Cardinal Health 200, LLC

Address

3651 Birchwood Dr, Waukegan, Illinois 60085-8337

Distribution

Distribution pattern

US 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

2023-09-20

Posted by FDA

2023-10-26

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #203388. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.