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U.S. Department of Health and Human Services

Class 2 Device Recall Medstream 81" (206cm) 20 Universal Administration Set with YSite

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  Class 2 Device Recall Medstream 81" (206cm) 20 Universal Administration Set with YSite see related information
Date Initiated by Firm August 03, 2012
Date Posted August 09, 2012
Recall Status1 Terminated 3 on January 23, 2015
Recall Number Z-2179-2012
Recall Event ID 62747
510(K)Number K090012  
Product Classification Set, administration, intravascular - Product Code FPA
Product Medstream 81" (206 cm) 20 Drop Standard bore Universal Administration Set with Y-Site, Sterile
Manufactured for MSD (Medical Specialties Distributors LLC, Stoughton, MA. Product of China
Product Number: MS721

Disposable Infusion set
Code Information LOT NUMBER: 20111115
Recalling Firm/
Manufacturer		 Medical Specialties Distributors, Inc.
800 Technology Center Dr
Stoughton MA 02072-4708
For Additional Information Contact
781-344-6000
Manufacturer Reason
for Recall		 Devices leaking at the Y-site
FDA Determined
Cause 2		 Process control
Action Medical Specialties Distributors LLC sent an Urgent Medical Recall letter dated August 2, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inspect their inventory and remove all affected product from use immediately. Further distribution of the affected product should be discontinued immediately. Customers were instructed to contact their customers and inform them of the recall; complete and return the acknowledgement form and fax to 781-344-8320 to arrange for a return and to contact the Customer Service Department at (800) 967-6400 with questions. For questions regarding this recall call 781-344-6000.
Quantity in Commerce 472 cases (50/case)
Distribution Nationwide 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 = FPA and Original Applicant = SHAN DONG WEI GAO GROUP MEDICAL POLYMER PRODUCTS
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