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Terminated

Electrode, Roller, Vaporization, 24FR (27050RK/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).

FDA Recall Z-1311-2013 · Posted 2013-05-11

Recalling FirmKarl Storz Endoscopy America Inc
Recall StatusTerminated
Product CodeFJL
Date Initiated2009-06-01
Date Terminated2013-05-13
Product Quantity9432 units

Reason for Recall

Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.

Firm Action

A Safety Alert dated May 29, 2009 was sent to affected customers. The letter informed them of possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products which may result in airborne contamination. Karl Storz requested consignees to inspect their inventory of the subject products thoroughly and look for small holes in the blister trays. Any identified units should be returned to Karl Storz, and a replacement package (6 units per package) will be provided to at no charge. The Karl Storz Customer Support number 1-800-421-0837 ext. 7577 was provided to obtain a Return Authorization Number (RMA) and arrange replacement. Questions and comments were forwarded to Technical Support at 1-800-421-0837 ext. 5350.

Root Cause

Packaging

Distribution Pattern

Distributed Nationwide and in Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K983569KSEA MONOPOLAR VAPORIZATION ELECTRODESKARL STORZ Endoscopy-America, Inc. · 1999-01-08K934647KARL STORZ CUTTING LOOP ELECTRODES MODIFICATIONKARL STORZ Endoscopy-America, Inc. · 1994-02-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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