Recall Z-0926-2017— Nurse Assist, Inc

Name: FDA recall Z-0926-2017
Creator: U.S. Food and Drug Administration
Published: 2016-10-04

Class I · Terminated

Class I FDA medical device recall by Nurse Assist, Inc, initiated 2016-10-04, terminated 2017-08-16. It names one FDA 510(k) clearance: K150143. Product: Normal Saline Flush 0.9% USP Sodium Chloride Injection Syringe, 3 ml fill, 5 ml fill and 10 ml fill. Product codes: 1203, 1205, 1210, 1210-BP Product usage: Saline flush. Reason: Potential contamination with B. cepacia..

Recalling firm: Nurse Assist, Inc
Classification: Class I
Status: Terminated
Initiated: 2016-10-04
Terminated: 2017-08-16
Firm location: Haltom City, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K150143 — Normal Saline FlushNurse Assist, Inc.·cleared 2015-08-31

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

Normal Saline Flush 0.9% USP Sodium Chloride Injection Syringe, 3 ml fill, 5 ml fill and 10 ml fill. Product codes: 1203, 1205, 1210, 1210-BP Product usage: Saline flush

Reason for recall

Potential contamination with B. cepacia.

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