Cardinal Health 200, LLC: Cardinal Health Monoject, 3 mL Syringe Luer-Lock Tip Soft Pack, REF 1180300777

Recall number

Z-0852-2024

Recalling firm

Cardinal Health 200, LLC

Product

Cardinal Health Monoject, 3 mL Syringe Luer-Lock Tip Soft Pack, REF 1180300777

Status

Open, Classified

Initiated

2023-12-28

Posted

2024-02-02

Terminated

not on file

Reason

Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.

Root cause

Process change control

Action

Cardinal Health issued an URGENT MEDICAL DEVICE PRODUCT CORRECTION notice to its consignees on 12/28/2023 via FedEx. The notice explained the problem with the device, risk to patient, and requested the following actions be taken: 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 Enteral Syringes with ENFit (6, 12, 35, 60 mL) that they should not be used with enteral syringe feeding pumps. 3. POST a copy of this notification in your storeroom and clinical areas 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. CONTACT the appropriate Customer Service group with questions related to this notification. Monday Friday between 8:00am - 5pm EST: " Hospital 800-965-5227 " Distributor 800-635-6021 " All Other Customers 888-444-5440 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. A subsequent recall letter dated 2/2/2024 flagged URGENT MEDICAL DEVICE PRODUCT RECALL was issued informing the customer that the recall now involves all sizes of the Cardinal Health brand Monoject sterile Syringe Luer-Lock Soft Packs and Monoject sterile Enteral Syringes with the ENFit connection. This letter supersedes the previous communications. The letter explains the issue, risk to health, and lists the actions that are required. The actions were: 1. REVIEW your inventory for the

Quantity

not on file

Distribution

Distribution US nationwide and Canada. Foreign distribution updated 9/6/2024 to only include Canada.

Lot, serial or model codes

UDI/DI 50192253033517 (Case), 20192253033516 (Box), 10192253033519 (Each), Lot Numbers: 230201, 230202, 221201, 221202, 230203, 230204, 230205, 230206, 230208, 230209, 230210, 230211, 230212, 230213, 230214, 230215, 230216, 230217, 230218, 230219, 230207, 230602, 230601, 230602, 230603, 230701, 230702, 230703, 230704, 230705, 230706, 230707

510(k) numbers

not on file

PMA numbers

not on file

Product code

FMF

Firm FEI

3001236905

Firm city

Waukegan

Firm state

IL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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