Monoject" 6 mL Syringe Luer-Lock Tip Soft Pack

FDA device recall Z-0146-2024 · posted 2023-10-26 · Open, Classified

Recall details

Recalling firm

Cardinal Health 200, LLC

Reason for recall

Demonstrated recognition and compatibility issues with syringe infusion pumps.

Action taken

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.

Root cause

Vendor change control

Status

Open, Classified

Product code

FMF

Quantity affected

3,936,682 units

Distribution

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

Date initiated

2023-09-20

Date posted

2023-10-26

Location

Waukegan, IL