| Class 2 Device Recall Monoject Standard Hypodermic Needle | |
Date Initiated by Firm | April 30, 2019 |
Create Date | July 23, 2019 |
Recall Status1 |
Completed |
Recall Number | Z-2042-2019 |
Recall Event ID |
82927 |
510(K)Number | K854547 |
Product Classification |
Needle, hypodermic, single lumen - Product Code FMI
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Product | Monoject Standard Hypodermic Needle, 20 G x 1-1/2" bulk
Item code: 8881200664 |
Code Information |
Lot Number: 905657, 906327, 906341 |
Recalling Firm/ Manufacturer |
Cardinal Health 200, LLC 15 Hampshire St Bldg 5 Mansfield MA 02048-1113
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = FMI
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