Recall Z-2073-2014 ยท GEX Powered Laser Surgical Instrument
Laser Peripherals LLC
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
| Date | Jul 17, 2014 (initiated Jun 20, 2014) |
| Status | Terminated |
| 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'. |
| Root cause | Labeling False and Misleading |
| Action | 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. |
| Quantity | 25 |
| Distribution | Nationwide Distribution to IL, IN, and MD |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030959 | BARE LASER FIBER MODELS DBLF-40, DBLF-60, DBLF-60-1, DCLF-600B, DSLF-60, DBLF-100 Laser Peripherals, LLC, Apr 25, 2003 |