Recall Z-1244-2009 ยท LHI Set, I.V. Fluid Transfer
Migada Inc.
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.
| Date | May 6, 2009 (initiated Dec 18, 2008) |
| Status | Terminated |
| Reason | Syringe adaptor is disintegrating when attached to the end of the syringe. |
| Root cause | 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 |
| Quantity | 900,000 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |