Device product
LP,Surgical Fibers, Bare Laser Fiber 600 micron, DBLF-60-2, Sterile EO. Laser surgical instrument for use in general and plastic surgery and in dermatology
Z-2073-2014
Product summary
- Event
- Event 68674
- Status
- Terminated
- Classification
- Class II
- Quantity
- 25
- Official record key
device-enforcement:Z-2073-2014
Official wording
Reason: Laser Peripherals LLC is recalling DBLF-60-2 Bare Laser due to a mislabeling that indicated a sterility expiration date as '2016-16' as opposed to the intended date of '2016-06'.
Code information: E14128 & E14129
Distribution pattern: Nationwide Distribution to IL, IN, and MD
Derived failure modes
-
Labeling or packaging
mislabeling