Recall Z-2476-2015— MRP, LLC dba AMUSA

Name: FDA recall Z-2476-2015
Creator: U.S. Food and Drug Administration
Published: 2015-07-02

Class II · Terminated

Class II FDA medical device recall by MRP, LLC dba AMUSA, initiated 2015-07-02, terminated 2017-04-03. It names one FDA 510(k) clearance: K120836. Product: 0.9% Sodium Chloride Injection, USP, 10mL in 12mL., Single use, Rx only, Sterile Solution.. Reason: Procedures for the acceptance and control of in-process product have not been adequately established..

Recalling firm: MRP, LLC dba AMUSA
Classification: Class II
Status: Terminated
Initiated: 2015-07-02
Terminated: 2017-04-03
Firm location: Nashville, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K120836 — 0.9% SODIUM CHLORIDE FLISH SYRINGEAm USA·cleared 2012-07-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.