Monoject Standard Hypodermic Needle, 16 G x 1-1/2" Item code:8881200045
FDA Recall Z-2039-2019 · Posted None
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Recalling FirmCardinal Health 200, LLC
Recall StatusCompleted
Product CodeFMI
Date Initiated2019-04-30
Reason for Recall
Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
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
Root Cause
Under Investigation by firm
Distribution Pattern
Nationwide Foreign: AU, BE, CA, DK, FI, GB, IE, NL
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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