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