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U.S. Department of Health and Human Services

Class 2 Device Recall IntelliSystem25 Inflation Device and Fluid Dispensing Syringe

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  Class 2 Device Recall IntelliSystem25 Inflation Device and Fluid Dispensing Syringe see related information
Date Initiated by Firm October 01, 2003
Date Posted November 19, 2003
Recall Status1 Terminated 3 on February 02, 2004
Recall Number Z-0138-04
Recall Event ID 27525
510(K)Number K884913  
Product Classification Injector And Syringe, Angiographic - Product Code DXT
Product IntelliSystem25 Inflation Device and Fluid Dispensing Syringe - Label on package reads in part: ''INTELLISYSTEM 25 WITH MAP152 MAP152 CONTAINS: MERIT ACCESS PLUS LARGE BORE HEMOSTASIS VALVE, TORGUE DEVICE AND METAL GUIDE WIRE INSERTION TOOL...MERIT MEDICAL'', Latex free. Sterile if package is unopened or undamaged. Part # 1525/B
Code Information Lot # A285003.
Recalling Firm/
Manufacturer		 Merit Medical Systems, Inc
1600 Merit Pkwy
South Jordan UT 84095-2416
For Additional Information Contact Stephanie Erskine
801-208-4349
Manufacturer Reason
for Recall		 There is a potential for the PETG blister trays to bond together with varying degrees of attachment. The potential for non-sterility exists when the attached trays are seperated by force and holes or cracks are generated in the seperated trays.
FDA Determined
Cause 2		 Other
Action Merit notified sales representatives, domestic and international accounts and dealers immediately by letter dated October 3, 2003. The manufacturer requests that the use of the affected inventory should immediately cease and that on-hand units should be promptly isolated from general inventory for simultaneous inspection by a site representative and a Merit sales representative.
Quantity in Commerce 626 units
Distribution Distributed nationwide. International distribution includes Canada, Japan, Korea, England and France.
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 = DXT and Original Applicant = MERIT MEDICAL SYSTEMS, INC.
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