T/S2 0.9% Sodium Chloride Injection, USP, AMUSA Sterile Field Flush Syringe, 10 mL in 12 mL Single Use Syringe, Rx only, Part no. 2S0706 Usage: Flush syringe.
FDA Recall Z-1808-2015 · Posted 2015-06-15
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Recalling FirmMRP, LLC dba AMUSA
Recall StatusTerminated
Product CodeNGT
Date Initiated2015-02-09
Date Terminated2015-06-22
Product Quantity1,080 units (3 cases)
Reason for Recall
Incorrect labeling of the expiration date
Firm Action
The firm, AMUSA, Inc., initiated the recall by telephone to the sole consignee on 02/09/2015. The consignee were informed of product, the problem and actions to be taken. The consignees verified that they were in possession of the product and that all the product has been destroyed.
If you have any questions, call 513-235-1940 or email: [email protected].
Root Cause
Process control
Distribution Pattern
US distribution to CA only.
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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