LP,Surgical Fibers, Bare Laser Fiber 600 micron, DBLF-60-2, Sterile EO. Laser surgical instrument for use in general and
FDA device recall Z-2073-2014 · posted 2014-07-17 · Terminated
Recall details
- Recalling firm
- Laser Peripherals LLC
- 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'.
- 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.
- Root cause
- Labeling False and Misleading
- Status
- Terminated
- Product code
- GEX
- Quantity affected
- 25
- Distribution
- Nationwide Distribution to IL, IN, and MD
- Date initiated
- 2014-06-20
- Date posted
- 2014-07-17
- Date terminated
- 2014-10-22
- Location
- Plymouth, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BARE LASER FIBER MODELS DBLF-40, DBLF-60, DBLF-60-1, DCLF-600B, DSLF-60, DBLF-100 (K030959) | Laser Peripherals, LLC | 2003-04-25 |