Recall Z-2073-2014— Laser Peripherals LLC

Name: FDA recall Z-2073-2014
Creator: U.S. Food and Drug Administration
Published: 2014-06-20

Class II · Terminated

Class II FDA medical device recall by Laser Peripherals LLC, initiated 2014-06-20, terminated 2014-10-22. It names one FDA 510(k) clearance: K030959. 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. 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'..

Recalling firm: Laser Peripherals LLC
Classification: Class II
Status: Terminated
Initiated: 2014-06-20
Terminated: 2014-10-22
Firm location: Plymouth, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K030959 — BARE LASER FIBER MODELS DBLF-40, DBLF-60, DBLF-60-1, DCLF-600B, DSLF-60, DBLF-100Laser Peripherals, LLC·cleared 2003-04-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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'.

Data sourced from openFDA. This site is unofficial and independent of the FDA.