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LP,Surgical Fibers, Bare Laser Fiber 600 micron… recallZ-2073-2014 · Laser Peripherals LLC · initiated Jun 20, 2014

Class II Terminated All recalls posted in July 2014

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Laser Peripherals LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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'.

FDA root cause category: Labeling False and Misleading

What the company is doing

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.

Recall details

Recall number
Z-2073-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Jun 20, 2014
Posted by the FDA
Jul 17, 2014
Recalling firm
Laser Peripherals LLC
Quantity
25
Product code
GEX
FDA submissions
K030959
Distribution
Nationwide Distribution to IL, IN, and MD

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

Code information (models, lots, serial numbers)

E14128 & E14129

Other devices under the same FDA submission

1 device cleared under K030959 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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