Migada Inc. P.O Box 888 Kiryat Shmona Israel 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Migada Inc. P.O Box 888 Kiryat Shmona Israel
Lot Codes / Batch Numbers
all lots
Products Sold
all lots
Migada Inc. P.O Box 888 Kiryat Shmona Israel is recalling TEVADAPTOR Closed Drug Reconstitution and Transfer System, a closed system used to prepare drugs, in due to Syringe adaptor is disintegrating when attached to the end of the syringe.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Syringe adaptor is disintegrating when attached to the end of the syringe.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026