Excelsior Medical 10mL Sterile Field Saline Flush ZR, 0.9% Sodium Chloride Injection, USP, REF EMZ10091280, Sterile, IV
Summary
The FDA issued a Class II for Excelsior Medical 10mL Sterile Field Saline Flush ZR, 0.9% Sodium Chloride Injec by MEDLINE INDUSTRIES, LP - Northfield. Reason: Sterility failure of the exterior of the syringe which may impact the device's ability to be laid on a sterile field..
Details
Source
Device Recall
External ID
Z-0898-2022
Action Date
2022-04-13
Status
Terminated
Category
device
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.
Lot/Code Info: Lot #3139133, Exp. 11/01/2022.
Quantity Affected: 7,800 pouched syringes
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.
Distribution
US Nationwide Distribution was made to KY, OK, and TX. There was no foreign/government/military distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-03-04
Company
Northfield, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 149 device recalls issued in the same week, part of 413 device-related FDA actions this month.
MEDLINE INDUSTRIES, LP - Northfield has 822 FDA actions in our database, including 822 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (MEDLINE INDUSTRIES, LP - Northfield) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does MEDLINE INDUSTRIES, LP - Northfield have FDA actions?
MEDLINE INDUSTRIES, LP - Northfield has 822 FDA actions in our database, including 822 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0898-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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