Z-0898-2022Class II

Excelsior Medical 10mL Sterile Field Saline Flush ZR, 0.9% Sodium Chloride Injection, USP, REF EMZ10091280...

Name: Z-0898-2022 Excelsior Medical 10mL Sterile Field Saline Flush ZR, 0.9% Sodium Chloride Injection, USP, REF EMZ10091280...
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2022-03-04
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2022-03-04 / Terminated / root cause: manufacturing process

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of 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... on 2022-03-04. FDA classified it as Class II and gives the reason as "Sterility failure of the exterior of the syringe which may impact the device's ability to be laid on a sterile field". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0898-2022
Classification: Class II
Status: Terminated
Initiated: 2022-03-04
Posted: 2022-04-08
Terminated: 2023-03-20
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
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.
Product code: NGT Saline, Vascular Access Flush
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.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: The recalling firm issued letters dated 3/4/2022 via regular mail informing the customer there was a sterility failure of the exterior of the syringe and in the event a syringe from the affected lot was placed on a sterile field, the sterile field may become compromised. The required actions were to immediately check their stock for the affected lot number, quarantine it, and then destroy it. The enclosed destruction form was to be completed listing the quantity of affected product destroyed, and once the form was returned, they would receive credit. If the product has been transferred to another individual or location, they were to notify them of the recall.
Quantity in commerce: 7,800 pouched syringes
Distribution: US Nationwide Distribution was made to KY, OK, and TX. There was no foreign/government/military distribution.
Product codes and lots: Lot #3139133, Exp. 11/01/2022.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0898-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0898-2022	Class II	Terminated	Voluntary: Firm initiated	2022-04-13	2022-04-08

Product code NGT

K082837Class IISterile Field Saline Pre-Filled Syringe(s)Excelsior Medical Corp. / cleared 2008-12-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)