Z-1244-2009

TEVADAPTOR Closed Drug Reconstitution and Transfer System, a closed system used to prepare drugs, including...

Name: Z-1244-2009 TEVADAPTOR Closed Drug Reconstitution and Transfer System, a closed system used to prepare drugs, including...
Creator: Migada Inc.
Published: 2008-12-18
License: https://open.fda.gov/license/

Simplivia Healthcare Ltd. / initiated 2008-12-18 / Terminated / root cause: design

FDA source

Migada Inc. began a recall of TEVADAPTOR Closed Drug Reconstitution and Transfer System, a closed system used to prepare drugs, including cytotoxic drugs, for intravenous infusion or... on 2008-12-18. The reason FDA records is "Syringe adaptor is disintegrating when attached to the end of the syringe". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1244-2009
Status: Terminated
Initiated: 2008-12-18
Posted: 2009-05-06
Terminated: 2009-07-27
Recalling firm: Simplivia Healthcare Ltd.
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.
Product code: LHI Set, I.V. Fluid Transfer
Reason for recall: Syringe adaptor is disintegrating when attached to the end of the syringe.
Root cause tag: design
FDA 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 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
Product codes and lots: all lots

Product code LHI

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)