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Terminated

Dr. Fog Endoscopic Fog Prevention Kit; model DF-3120. Each box contains 40 packages. Each package contains one Dr. Fog treated sponge.

FDA Recall Z-0828-03 · Posted 2003-05-15

Recalling FirmAspen Surgical Products, Inc.
Recall StatusTerminated
Product CodeGCJ
Date Initiated2003-04-30
Date Terminated2003-11-13
Product Quantity299 boxes

Reason for Recall

Sterility compromised - incomplete sterile package seal.

Firm Action

The firm called each customer on 4/30/03 and requested that the product be returned. Distributors were asked to notify their customers of the recall.

Root Cause

Packaging process control

Distribution Pattern

Nationwide, Japan and United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K932449DR. FOGO.R. Concepts, Inc. · 1993-08-11

Official Source

View FDA Recall →

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

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