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U.S. Department of Health and Human Services

Class 2 Device Recall Monoject Standard Hypodermic Needle

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  Class 2 Device Recall Monoject Standard Hypodermic Needle see related information
Date Initiated by Firm April 30, 2019
Create Date July 23, 2019
Recall Status1 Completed
Recall Number Z-2040-2019
Recall Event ID 82927
510(K)Number K854547  
Product Classification Needle, hypodermic, single lumen - Product Code FMI
Product Monoject Standard Hypodermic Needle, 18 G x 1-1/2"

Item code: 8881200078
Code Information Lot Number: 907007
Recalling Firm/
Manufacturer		 Cardinal Health 200, LLC
15 Hampshire St Bldg 5
Mansfield MA 02048-1113
Manufacturer Reason
for Recall		 Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
FDA Determined
Cause 2		 Under Investigation by firm
Action Cardinal Health issued notification letter by mail on 4/30/19 advising product defect, health risk and action to take: 1. INSPECT inventory for the affected 2. SEGREGATE and QUARANTINE all on-hand product; 3. RETURN acknowledgment form via fax to 847-689-9101 or 614-652-9648, whether or not you have affected product, indicating the product code, lot and quantity of product quarantined or discarded. 4. NOTIFY any customers to whom you may have distributed, or forwarded product affected by this recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. 5. CONTACT the appropriate Customer Service group to arrange for return and credit/replacement of any affected product Monday  Friday between 8:00am - 5:00pm EST. Questions contact Cardinal Health at 800-292-9332
Distribution Nationwide Foreign: AU, BE, CA, DK, FI, GB, IE, NL
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FMI and Original Applicant = SHERWOOD MEDICAL CO.
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