Recall Z-1808-2015— MRP, LLC dba AMUSA

Name: FDA recall Z-1808-2015
Creator: U.S. Food and Drug Administration
Published: 2015-02-09

Class II · Terminated

Class II FDA medical device recall by MRP, LLC dba AMUSA, initiated 2015-02-09, terminated 2015-06-22. It names one FDA 510(k) clearance: K120836. Product: 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.. Reason: Incorrect labeling of the expiration date.

Recalling firm: MRP, LLC dba AMUSA
Classification: Class II
Status: Terminated
Initiated: 2015-02-09
Terminated: 2015-06-22
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

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.

Reason for recall

Incorrect labeling of the expiration date

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