Z-2073-2014Class II

LP,Surgical Fibers, Bare Laser Fiber 600 micron, DBLF-60-2, Sterile EO. Laser surgical instrument for use in...

Name: Z-2073-2014 LP,Surgical Fibers, Bare Laser Fiber 600 micron, DBLF-60-2, Sterile EO. Laser surgical instrument for use in...
Creator: Laser Peripherals LLC
Published: 2014-06-20
License: https://open.fda.gov/license/

Laser Peripherals LLC / initiated 2014-06-20 / Terminated / root cause: labeling and UDI

FDA source

Laser Peripherals LLC began a recall of 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 on 2014-06-20. FDA classified it as Class II and gives the reason as "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'". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2073-2014
Classification: Class II
Status: Terminated
Initiated: 2014-06-20
Posted: 2014-07-17
Terminated: 2014-10-22
Recalling firm: Laser Peripherals LLC
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
Product code: GEX Powered Laser Surgical Instrument
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'.
Root cause tag: labeling and UDI
FDA 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 in commerce: 25
Distribution: Nationwide Distribution to IL, IN, and MD
Product codes and lots: E14128 & E14129

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2073-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2073-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-23	2014-07-17

Product code GEX

K030959Class IIBare Laser Fiber Models Dblf-40, Dblf-60, Dblf-60-1, Dclf-600B, Dslf-60, Dblf-100Laser Peripherals, LLC / cleared 2003-04-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)