Z-2073-2014 Class II Terminated
FDA device recall Z-2073-2014 was initiated by Laser Peripherals LLC on June 20, 2014 and is designated Class II. 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'. The recall status is terminated (terminated October 22, 2014). Affected quantity: 25.
Recall Details
- Product Type
- Devices
- Report Date
- July 23, 2014
- Initiation Date
- June 20, 2014
- Termination Date
- October 22, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 25
Product Description
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
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'.
Distribution Pattern
Nationwide Distribution to IL, IN, and MD
Code Information
E14128 & E14129