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Terminated

0.9% Sodium Chloride Injection, USP, 10mL in 12mL., Single use, Rx only, Sterile Solution.

FDA Recall Z-2476-2015 · Posted 2015-08-27

Recalling FirmMRP, LLC dba AMUSA
Recall StatusTerminated
Product CodeNGT
Date Initiated2015-07-02
Date Terminated2017-04-03
Product Quantity551 cases

Reason for Recall

Procedures for the acceptance and control of in-process product have not been adequately established.

Firm Action

The firm notified their consignees of the recall by Fed Ex on 07/02/2015. The firm requested the return of the product. Distributors were instructed to notify their customers.

Root Cause

Packaging process control

Distribution Pattern

Distributed in the states of CA. PA, VA, TX, MA, MD, WV, UT, FL, and TN.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K1208360.9% SODIUM CHLORIDE FLISH SYRINGEAm USA · 2012-07-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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