Exact FDA event identifier

Event 64454

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket: January 04, 2013
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: PhotoMedex, Inc.

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

The product is labeled in part "Surgical Laser Technologies, Inc. Montgomeryville, PASLT Fiber Delivery SystemSterileNon-Pyrogenic***. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.

Z-0005-2014

Recall number: Z-0005-2014
Initiated: January 04, 2013
Classification: Class II
Status: Terminated
Recalling firm: PhotoMedex, Inc.
Quantity: 549

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

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Inspect official wording and provenance

Reason for recall

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

Code information

Lot number 226201

Distribution pattern

Worldwide Distribution-USA including the states of AR, KS and OH, and the countries of Germany, South Africa and the United Kingdom.