Device product
- 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.
Z-1642-2013
Product summary
- Event
- Event 65205
- Status
- Terminated
- Classification
- Class II
- Quantity
- 90
- Official record key
device-enforcement:Z-1642-2013
Official wording
Reason: The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
Code information: 122590, 123372, 123215, 122309.
Distribution pattern: Nationwide Distribution.
Derived failure modes
-
Sterility assurance
sterile barrier for reprocessed medical devices became compromised