Recall Z-2394-2012— Amsino Medical USA

Name: FDA recall Z-2394-2012
Creator: U.S. Food and Drug Administration
Published: 2012-08-15

Class III · Terminated

Class III FDA medical device recall by Amsino Medical USA, initiated 2012-08-15, terminated 2013-08-13. It names one FDA 510(k) clearance: K111034. Product: 0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 10 mL in 12 mL Single Use Syringe, Rx only, List no. 1078-20, made in Nashville, TN, manufactured for Hospira, Inc., Lake Forest, IL 60045 USA. Flush syringe.. Reason: One lot of 0.9% Sodium Chloride Flush syringe, 3 mL in 12 mL may be mislabeled as 0.9% Sodium Chloride Flush syringe, 10 mL in 12 mL..

Recalling firm: Amsino Medical USA
Classification: Class III
Status: Terminated
Initiated: 2012-08-15
Terminated: 2013-08-13
Firm location: Nashville, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K111034 — AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGEAm USA·cleared 2011-07-14

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, Pre-Filled Flush Solution, 10 mL in 12 mL Single Use Syringe, Rx only, List no. 1078-20, made in Nashville, TN, manufactured for Hospira, Inc., Lake Forest, IL 60045 USA. Flush syringe.

Reason for recall

One lot of 0.9% Sodium Chloride Flush syringe, 3 mL in 12 mL may be mislabeled as 0.9% Sodium Chloride Flush syringe, 10 mL in 12 mL.

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