Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, REF 1188100777
FDA Recall Z-0310-2025 · Posted 2024-11-08
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Recalling FirmCardinal Health 200, LLC
Recall StatusOpen, Classified
Product CodeMEG
Date Initiated2024-09-25
Product Quantity371,326 units
Reason for Recall
Certain lots of listed lots of Cardinal Health Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack have demonstrated incompatibility with needleless Intravenous (IV) connectors. Cardinal Health recommends that they not be used for administration of IV push insulin via needleless connector.
Firm Action
Cardinal Health issued an URGENT MEDICAL DEVICE PRODUCT RECALL to its consignees on 09/25/2024 via overnight mail. The notice explained the issue, risk to health, and requested the following actions:
1. REVIEW inventory for the affected product code and lots.
2. COMMUNICATE with all personnel who utilize the Cardinal Health Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack that it should not be used for administration of IV push insulin via needleless connector.
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 or to whom you plan to send the product 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 [email protected], 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 800-964-5227
" Federal Government 800-444-1166
" Distributor 800-635-6021
" All Other Customers 888-444-5440
Root Cause
Under Investigation by firm
Distribution Pattern
Nationwide
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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