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U.S. Department of Health and Human Services

Class 2 Device Recall Terumo Survet Needle, 25G x 5/8 for use in the aspiration and/or injection of fluids.

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  Class 2 Device Recall Terumo Survet Needle, 25G x 5/8 for use in the aspiration and/or injection of fluids. see related information
Date Initiated by Firm February 08, 2019
Create Date July 22, 2019
Recall Status1 Terminated 3 on May 08, 2020
Recall Number Z-2003-2019
Recall Event ID 82212
510(K)Number K121607  
Product Classification Needle, hypodermic, single lumen - Product Code FMI
Product Terumo Sur-vet Needle, 25G x 5/8", Product Code 100280
Code Information Lot Numbers 180814C 181002C 181009C 
Recalling Firm/
Manufacturer		 Terumo Medical Corporation
950 Elkton Blvd
Elkton MD 21921-5322
For Additional Information Contact Terumo Medical Corporation Customer Service
732-907-5022
Manufacturer Reason
for Recall		 There is a potential for a loss of package integrity that may compromise the sterility of the product.
FDA Determined
Cause 2		 Packaging
Action Urgent Voluntary Medical Device Recall notification letters dated 2/8/19 were sent to customers.
Quantity in Commerce 563,000
Distribution The products were distributed to the following US states: FL, IN, KS, KY, MA, MO, NH, NV, PA, SC, TN, and TX.
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 = FMI and Original Applicant = TERUMO (PHILIPPINES) CORPORATION
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