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Terminated

DeRoyal Lap Chole Tray, REF 89-4823.06, Rx, Sterile EO. (custom surgical kit)

FDA Recall Z-0198-2009 · Posted 2008-11-07

Recalling FirmDeRoyal Industries Inc
Recall StatusTerminated
Product CodeKDD
Date Initiated2008-10-01
Date Terminated2009-12-02
Product Quantity30 kits

Reason for Recall

Surgical kits contained a recalled Endopath ETX 35 mm Endoscopic Linear Cutter White Reload/Cartridges.

Firm Action

The firm sent out recall notices to their sales representatives, the distributors, and the hospitals addressed to the Recall Coordinator/OR Supervisor on 10/2/08. These notices stated that the recalling firm's sales representatives would perform the field correction in lieu of returning the kits. Contact DeRoyal Industries, Inc. at 1-865-362-6157 for assistance.

Root Cause

Nonconforming Material/Component

Distribution Pattern

LA & KY

Official Source

View FDA Recall →

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

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