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

• Date Initiated by Firm: February 08, 2019
• Create Date: July 22, 2019
• Recall Status: Terminated on May 08, 2020
• Recall Number: Z-2001-2019
• 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 100220
• Code Information: Lot Numbers 180706C
• FEI Number: 1118880
• 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: 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

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