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Class 2 Device Recall SIMS Portex |
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Date Initiated by Firm |
December 12, 2003 |
Date Posted |
July 20, 2004 |
Recall Status1 |
Terminated 3 on May 02, 2006 |
Recall Number |
Z-0569-04 |
Recall Event ID |
27986 |
510(K)Number |
K980466
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Product Classification |
Tube Tracheostomy And Tube Cuff - Product Code JOH
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Product |
PER-FIT Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube REF # 511080 |
Code Information |
Lot Number: K223373 |
Recalling Firm/ Manufacturer |
Smiths Medical ASD, Inc. 10 Bowman Dr Keene NH 03431-5043
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For Additional Information Contact |
Timothy J. Talcott 800-258-5361
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Manufacturer Reason for Recall |
Lid tray incorrectly labeled as Tube I.D. 7.0 mm instead of correct size 8.0 mm
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FDA Determined Cause 2 |
Other |
Action |
Smiths Medical contacted dealers via telephone on December 12, 2003. The direct customers to whom product was shipped contacted via a visit by the Smiths Medical sales representative Monday, December 15, 2003 through December 12,2 003.
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Quantity in Commerce |
30 CASES (2/CASE) |
Distribution |
AZ, CA, CO, CT, FL, GA, IN, MA, NJ, NY, TN, TX, WI |
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 = JOH and Original Applicant = SIMS PORTEX, INC.
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