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U.S. Department of Health and Human Services

Class 2 Device Recall Excelsior Medical

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  Class 2 Device Recall Excelsior Medical see related information
Date Initiated by Firm March 04, 2022
Create Date April 08, 2022
Recall Status1 Terminated 3 on March 20, 2023
Recall Number Z-0898-2022
Recall Event ID 89795
510(K)Number K082837  
Product Classification Saline, vascular access flush - Product Code NGT
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.
Code Information Lot #3139133, Exp. 11/01/2022.
Recalling Firm/
Manufacturer		 MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information Contact Karin Johnson
866-359-1704
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NGT and Original Applicant = EXCELSIOR MEDICAL CORP.
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