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U.S. Department of Health and Human Services

Class 2 Device Recall Medstream 81" (206 cm) 20 drop Universal Administration Sets

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  Class 2 Device Recall Medstream 81" (206 cm) 20 drop Universal Administration Sets see related information
Date Initiated by Firm October 10, 2014
Date Posted March 13, 2015
Recall Status1 Terminated 3 on June 23, 2015
Recall Number Z-1277-2015
Recall Event ID 70143
510(K)Number K090012  
Product Classification Set, administration, intravascular - Product Code FPA
Product Medstream 81" (206 cm) 20 drop Universal Administration Sets.

Disposable IV infusion set with 3 year expiration date.
Code Information Model # MS721, Lot # 20111115.
Recalling Firm/
Manufacturer		 US Infusion Inc dba Trucare Biomedix-USA
6356 Manor Ln
Suite 103
South Miami FL 33143-4960
For Additional Information Contact Marc Parness
866-593-8444
Manufacturer Reason
for Recall		 Several complaints regarding the IV sets leaking at the Y site.
FDA Determined
Cause 2		 Unknown/Undetermined by firm
Action On December 10, 2014 the firm sent an URGENT DRUG RECALL to its consignees. Instructions were to immediately examine inventory and quarantine all product subject to the recall. Customers were asked to complete and return the response form. For returned goods instructions contact Roberta Parness at 866-593-8444 or via email at rparness@tcbiomedix.com.
Quantity in Commerce 62,700 IV sets
Distribution Distributed in the states of TX, IL, MA, OH, CA, and GA.
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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