FDAClass IIApril 13, 2022

Excelsior Medical recall: Sterility Concern

Excelsior Medical 10mL Sterile Field Saline Flush ZR, 0.9% Sodium Chloride Injection, USP, REF EMZ10091280, Sterile, IV Flush Only, Contents of…

Why was Excelsior Medical recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #3139133, Exp. 11/01/2022.

Product
Excelsior Medical 10mL Sterile Field Saline Flush ZR, 0.9% Sodium Chloride Injection, USP, REF EMZ10091280, Sterile, IV Flush Only, Contents of…
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
7,800 pouched syringes
Distribution
US Nationwide Distribution was made to KY, OK, and TX. There was no foreign/government/military distribution.
Recall date
April 13, 2022
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls