TEVADAPTOR Closed Drug Reconstitution and Transfer System, a closed system used to prepare drugs, including cytotoxic dr
FDA device recall Z-1244-2009 · posted 2009-05-06 · Terminated
Recall details
- Recalling firm
- Migada Inc.
- Reason for recall
- Syringe adaptor is disintegrating when attached to the end of the syringe.
- Action taken
- 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.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- LHI
- Quantity affected
- 900,000 units
- Distribution
- Nationwide Distribution
- Date initiated
- 2008-12-18
- Date posted
- 2009-05-06
- Date terminated
- 2009-07-27
- Location
- Kiryat Shmona, Israel
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TEVADAPTOR, CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM (K071741) | Migada Plant | 2007-09-24 |
| TEVADAPTOR CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM (K051669) | Migada Plant | 2005-09-01 |