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U.S. Department of Health and Human Services

Class 2 Device Recall TEVADAPTOR

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  Class 2 Device Recall TEVADAPTOR see related information
Date Initiated by Firm December 18, 2008
Date Posted May 06, 2009
Recall Status1 Terminated 3 on July 27, 2009
Recall Number Z-1244-2009
Recall Event ID 51421
510(K)Number K051669  K071741  
Product Classification I.V. Fluid Transfer Set - Product Code LHI
Product TEVADAPTOR Closed Drug Reconstitution and Transfer System, a closed system used to prepare drugs, including cytotoxic drugs, for intravenous infusion or injection. Model number is MG412110. The device is a single use device.
Code Information all lots
Recalling Firm/
Manufacturer		 Migada Inc.
P.O Box 888
Kiryat Shmona Israel
Manufacturer Reason
for Recall		 Syringe adaptor is disintegrating when attached to the end of the syringe.
FDA Determined
Cause 2		 Component design/selection
Action A Field Safety Notice, dated 12/8/2008, was sent to all TEVADAPTOR customers advising them not to use drugs containing N,N-Dimethylacetamide. Teva Medical is presently revising the instruction leaflet supplied with each TEVADAPTOR to include a warning against the use of drugs containing N,N-Dimethylacetamide. Teva Medical will introduce this revised leaflet to current production as soon as practicable. In the meantime, Teva Medical will advise all users of the potential problem by means of the Urgent Field Safety Notice. Customers are to ensure that the safety notice is passed to all those who need to be aware within their organizations. Questions should be directed to their local contacts at B Braun, USA.
Quantity in Commerce 900,000 units
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 = LHI and Original Applicant = MIGADA PLANT
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