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
- Recall Number
- Z-1244-2009
- Event Number
- 51421
- Firm
- Migada Inc. P.O Box 888 Kiryat Shmona Israel
- FEI Number
- 3002807615
- Product Code
- LHI
- Status
- Terminated
- Root Cause
- Component design/selection
- Initiated
- December 18, 2008
- Posted
- May 6, 2009
- Terminated
- July 27, 2009
Description
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.
Syringe adaptor is disintegrating when attached to the end of the syringe.
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.
Nationwide Distribution
900,000 units