FDAFDA · Food and drugs·Recall number Z-1375-2016
Boston Scientific TSX Transseptal Needle, Model Number M004TSX60o; Used to create the primary puncture in the interatrial septum when passing an intruder and/or catheter through the septum from the right side of the heart to the left side.
Published April 20, 2016 · Recall initiated: March 15, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Merit Medical Systems, Inc. is voluntarily conducting a recall of one lot of the TSX" Transseptal Needle due to a discrepancy between the labeling and the actual configuration of the device in the packaging. The curve dimensional values on the labels of this lot incorrectly indicate a 50¿ curve, rather than the correct 86¿ curve
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Merit Medical Systems, Inc.
- Distributor
- Distributed to one customer in the US.
- Lot
- Lot Q823423, Exp 7/31/2018
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.