Date Initiated by Firm |
September 29, 2009 |
Date Posted |
December 14, 2009 |
Recall Status1 |
Terminated 3 on December 15, 2009 |
Recall Number |
Z-0517-2010 |
Recall Event ID |
53557 |
510(K)Number |
K082063
|
Product Classification |
Short Sheath Introducer - Product Code DYB
|
Product |
Merit Medical Systems, Inc. Prelude Short Sheath Introducer REF/CAT No.: PSS-6F-4-018MT Prelude SHORT SHEATH INTRODUCER 21G 6F-SMT 4 cm to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries. |
Code Information |
Lot #: F696474 |
Recalling Firm/ Manufacturer |
Merit Medical Systems, Inc. 1600 Merit Pkwy South Jordan UT 84095
|
For Additional Information Contact |
801-253-1600
|
Manufacturer Reason for Recall |
Potential sterility breach caused by excessive shipment damage.
|
FDA Determined Cause 2 |
Other |
Action |
Merit Medical Customers were contacted directly by phone and letter on 9/29/09. Customers were instructed to identify and quarantine all unused affected product. Further information was available at 801-208-4365. |
Quantity in Commerce |
4 Sheaths |
Distribution |
US (AL, LA, MO, KY, TN, GA). No military, government or foreign distribution. |
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 = DYB and Original Applicant = MERIT MEDICAL SYSTEMS, INC.
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