Recall Z-0898-2022— MEDLINE INDUSTRIES, LP - Northfield

Name: FDA recall Z-0898-2022
Creator: U.S. Food and Drug Administration
Published: 2022-03-04

Class II · Terminated

Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2022-03-04, terminated 2023-03-20. It names one FDA 510(k) clearance: K082837. Product: Excelsior Medical 10mL Sterile Field Saline Flush ZR, 0.9% Sodium Chloride Injection, USP, REF EMZ10091280, Sterile, IV Flush Only, Contents of Package may be dropped on a Sterile Field, 1 syringe/pouch, 35 pouches/box, 8 boxes/case.. Reason: Sterility failure of the exterior of the syringe which may impact the device's ability to be laid on a sterile field..

Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Classification: Class II
Status: Terminated
Initiated: 2022-03-04
Terminated: 2023-03-20
Firm location: Northfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K082837 — STERILE FIELD SALINE PRE-FILLED SYRINGE(S)Excelsior Medical Corp.·cleared 2008-12-18

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

Excelsior Medical 10mL Sterile Field Saline Flush ZR, 0.9% Sodium Chloride Injection, USP, REF EMZ10091280, Sterile, IV Flush Only, Contents of Package may be dropped on a Sterile Field, 1 syringe/pouch, 35 pouches/box, 8 boxes/case.

Reason for recall

Sterility failure of the exterior of the syringe which may impact the device's ability to be laid on a sterile field.

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