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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. |
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Date Initiated by Firm |
February 08, 2019 |
Create Date |
July 22, 2019 |
Recall Status1 |
Terminated 3 on May 08, 2020 |
Recall Number |
Z-2001-2019 |
Recall Event ID |
82212 |
510(K)Number |
K121607
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Product Classification |
Needle, hypodermic, single lumen - Product Code FMI
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Product |
Terumo Sur-vet Needle, 25G x 5/8", Product Code 100220 |
Code Information |
Lot Numbers 180706C |
Recalling Firm/ Manufacturer |
Terumo Medical Corporation 950 Elkton Blvd Elkton MD 21921-5322
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For Additional Information Contact |
Terumo Medical Corporation Customer Service 732-907-5022
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Manufacturer Reason for Recall |
There is a potential for a loss of package integrity that may compromise the sterility of the product.
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FDA Determined Cause 2 |
Packaging |
Action |
Urgent Voluntary Medical Device Recall notification letters dated 2/8/19 were sent to customers. |
Quantity in Commerce |
440,000 |
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
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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.
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510(K) Database |
510(K)s with Product Code = FMI and Original Applicant = TERUMO (PHILIPPINES) CORPORATION
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