Recall Z-1709-2015— MRP, LLC dba AMUSA

Name: FDA recall Z-1709-2015
Creator: U.S. Food and Drug Administration
Published: 2015-04-27

Class II · Terminated

Class II FDA medical device recall by MRP, LLC dba AMUSA, initiated 2015-04-27, terminated 2016-05-02. It names one FDA 510(k) clearance: K133685. Product: 0.9% Sodium Chloride Injection, USP, Flush Syringe, 10 mL in 12 mL, Sterile, Rx only, Code No. 2T0806 Usage: Flush syringe.. Reason: Incorrect expiration date on label.

Recalling firm: MRP, LLC dba AMUSA
Classification: Class II
Status: Terminated
Initiated: 2015-04-27
Terminated: 2016-05-02
Firm location: Nashville, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K133685 — 0.9% SODIUM CHLORIDE FLUSH SYRINGEAm USA·cleared 2014-08-13

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, Flush Syringe, 10 mL in 12 mL, Sterile, Rx only, Code No. 2T0806 Usage: Flush syringe.

Reason for recall

Incorrect expiration date on label

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