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U.S. Department of Health and Human Services

Class 2 Device Recall Safedraw Venous Close Loop System

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  Class 2 Device Recall Safedraw Venous Close Loop System see related information
Date Initiated by Firm May 04, 2012
Date Posted July 06, 2012
Recall Status1 Terminated 3 on January 14, 2013
Recall Number Z-1946-2012
Recall Event ID 61832
510(K)Number K885235  
Product Classification Computer, blood pressure - Product Code DSK
Product Safedraw Venous Close Loop System, Blood Sampling Set, packaged in a tyvek bag, Model/Part Number 688695, Argon Critical Care Systems, Singapore Pte. Ltd., 198 Yishun Avenue 7, Singapore 768028.

The blood sampling set is intended to be used for closed-loop blood sampling from the patient without the system being exposed to the outside environment.
Code Information Lot Number 204889, Expiration Date March 2017
Recalling Firm/
Argon Medical Devices, Inc
1445 Flat Creek Rd
Athens TX 75751-5002
For Additional Information Contact
Manufacturer Reason
for Recall
Some of the kits may exhibit a potential defect with the pouch seal. The pouch issue may compromise the sterile barrier.
FDA Determined
Cause 2
Action Argon Medical Devices sent an "URGENT MEDICAL DEVICE RECALL" letter dated May 4, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Recall Response Form was attached to the letter for customers to complete and return to the firm via fax to 903-577-9393. Contact the firm at CRS@argonmedical.com for questions regarding this recall.
Quantity in Commerce 10 pieces
Distribution Distributed only in Missouri.
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 = DSK and Original Applicant = SPECTRAMED, INC.