Recall Z-2073-2014
Laser Peripherals LLC · initiated June 20, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: E14128 & E14129
Reason for recall
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'.
FDA-determined cause: Labeling False and Misleading
Action taken
Laser Peripherals contacted all consignees via telephone on June 20, 2014, in regard to the product being recalled by following the firm's Standard Operating Procedures. The SOP's included Instructions to immediately stop the use of the recalled product and provided other communications related to the recall. For questions regarding this recall call 612-280-1318.
Details
- Recall number
- Z-2073-2014
- Initiated
- June 20, 2014
- Posted by FDA
- July 17, 2014
- Terminated
- October 22, 2014
- Product code
- GEX – Powered Laser Surgical Instrument
- Quantity
- 25
- Distribution
- Nationwide Distribution to IL, IN, and MD
- Recalling firm
- Laser Peripherals LLC, Plymouth, MN