FDAFDA · Food and drugs·Recall number Z-1642-2013
- Turbosonics Mini-Flared ABS Tip, 45 Degree OZil 12 Degree, (Purplish/ Pink) 0.9mm Ref. 8065751177 Lot 123215 - TurboSonics¿ Mini-Flared ABS¿ Tip, 20 Degree Tip Angle, 45¿ Kelman, (Purplish Pink/Silver) 0.9mm Ref. 8065750853 Lot 122590, 123372 - TurboSonics¿ Tapered ABS¿ MicroTip" 30¿ Kelman, (Purple/Silver) 0.9mm Ref. 8065750263 Lot 122309 Series 20000" Legacy¿ TurboSonics¿ Flared ABS MicroTip, 30 Degree, Kelman, (Pink) 0.9mm Ref. 8065740839 Lot. 122309 Phacofragmentation system.
Published July 10, 2013 · Recall initiated: May 3, 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 seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Surgical Instrument Service And Savings, Inc.
- Distributor
- Nationwide Distribution.
- Lot
- 122590, 123372, 123215, 122309.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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