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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 Recall
Medstream 81" (206cm) 20 Universal Administration Set with YSite
see related information
Date Posted August 09, 2012
Recall Status1 Open
Recall Number Z-2179-2012
Recall Event ID 62747
Premarket Notification
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, Massachusetts 02072-4708
Consumer Instructions No consumer action necessary
Manufacturer Reason
for Recall
Devices leaking at the Y-site
FDA Determined
Cause 2
PRODUCTION CONTROLS: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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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