Recall Z-2948-2018— Medline Industries Inc

Name: FDA recall Z-2948-2018
Creator: U.S. Food and Drug Administration
Published: 2018-02-01

Class II · Terminated

Class II FDA medical device recall by Medline Industries Inc, initiated 2018-02-01, terminated 2020-10-05. It names one FDA 510(k) clearance: K142620. Product: Medline 0.9 % Sodium Chloride Injection, USP 5 mL in 10 mL Syringe ZR Intended for flushing IV catheters and IV tubing only.. Reason: Packaged with an incorrect overwrap..

Recalling firm: Medline Industries Inc
Classification: Class II
Status: Terminated
Initiated: 2018-02-01
Terminated: 2020-10-05
Firm location: Northfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K142620 — 0.9% Sodium Chloride Injection, USP - 2.5 mL in 3 mL Syringe, 0.9% Sodium Chloride Injection, USP-3mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 5 mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 10 mL in 10 mL SyringeExcelsior Medical Corporation·cleared 2014-12-12

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

Medline 0.9 % Sodium Chloride Injection, USP 5 mL in 10 mL Syringe ZR Intended for flushing IV catheters and IV tubing only.

Reason for recall

Packaged with an incorrect overwrap.

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