FDA-Device2022-04-13Class II
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.
MEDLINE INDUSTRIES, LP - Northfield
Hazard
Sterility failure of the exterior of the syringe which may impact the device's ability to be laid on a sterile field.
Sold states
US Nationwide Distribution was made to KY, OK, and TX. There was no foreign/government/military distribution.
Affected count
7,800 pouched syringes
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0898-2022Don't want to check this manually?
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