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U.S. Department of Health and Human Services

Class 2 Device Recall TEVADAPTOR

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 Class 2 Recall
TEVADAPTOR
see related information
Date Posted May 06, 2009
Recall Status1 Terminated on July 27, 2009
Recall Number Z-1244-2009
Recall Event ID 51421
Premarket Notification
510(K) Number
K051669 
Product Classification Set, I.V. Fluid Transfer - 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
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
Syringe adaptor is disintegrating when attached to the end of the syringe.
FDA Determined
Cause 2
DESIGN: 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 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 = LHI and Original Applicant = MIGADA PLANT
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