FDAFDA · Food and drugs·Recall number Z-1984-2013
Product Name: nanoPOINT Injector System, item number 37-0000-08. Intended to fold and insert a STAAR Surgical Collamer¿ nanoFLEX or Afinity IOLs, through surgical procedure in a human eye.
Published August 28, 2013 · Recall initiated: August 5, 2013
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
The firm initiated this recall of one lot (121402) of nanoPOINT Injectors after they noticed that Tyvek lids might have been damaged and, therefore, the stability of the sterile barrier might be negatively affected.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Medicel Ag
- Distributor
- Nationwide Distribution.
- Lot
- Item number 37-0000-08 Lot number of the recalled products: LOT121402
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Switzerland
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.