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Terminated

Advance Medical''s, The Closed Camera System, 9'' x 96'' (23cm x 244cm), REF 04-CC900, Lot 40475C4144, Sterile, Manufactured by Advance Medical Designs, Inc., 1241 Atlanta Industrial Drive, Marietta, GA 80066 USA.

FDA Recall Z-1036-04 · Posted 2004-07-20

Recalling FirmAdvance Medical Designs Inc
Recall StatusTerminated
Product CodeJAA
Date Initiated2004-06-18
Date Terminated2004-09-03
Product Quantity2340 units, *amended to include additional 250 units

Reason for Recall

The product may come apart when excessive force is applied to the coupler.

Firm Action

Consignees were notified on 6/17/2004 first by telephone on 6/17/2004 with f/u letter sent 6/18/04.

Root Cause

Other

Distribution Pattern

Nationwide and Canada

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K850959EQUIPMENT SNAP KOVERSAdvance Medical Designs, Inc. · 1985-04-09

Official Source

View FDA Recall →

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

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