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
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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 |
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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 = LHI
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