Reported Oct 9, 2013 · Terminated

The product is labeled in part "***Surgical Laser Technologies, Inc. Montgomeryville, PA***SLT Fiber Delivery…

PhotoMedex, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: PhotoMedex, Inc. · 147 Keystone Dr · Montgomeryville, PA · 18936-9638

Is this the product you have?

9 of 9 products

Products covered by this recall
Model / numberProduct as published
0041-3082The product is labeled in part "***Surgical Laser Technologies, Inc. Montgomeryville, PA***SLT Fiber Delivery System***Sterile***Non-Pyrogenic***. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/
0041-3112SLT-SSRH 11, Catalog/
0042-0075SLT-SSRH 4-SMA, Catalog/
0042-0076SLT-SSRH 5-SMA, Catalog/
0042-0077SLT-SSRH 6-SMA, Catalog/
0042-0078SLT-SSRH 7-SMA, Catalog/
0042-0079SLT-SSRH 8-SMA, Catalog/
0041-4931SLT-SSRH 9-SMA, Catalog/
0042-0081.and SLT-SSRH 10-SMA, Catalog/ Indicated for the incision, excision, coagulations, and vaporization of soft tissue.
Lot codes and dates
  • Lot number 226201
Amount recalled
549

Where it was sold

Why it was recalled

Firm became aware that some products within the specified lot may not have been sealed appropriately, thus compromising the sterile barrier.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 16, 2014 · Data as of Sep 19, 4:53 PM UTC

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