FDA Device

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.

Hazard

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

What You Should Do

Remedy

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

Products

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,
Brand
Advance Medical Designs Inc
UPC
Product #04-CC900, Lot #40475C4144 and 40474C4148 *amend to include 40494C4154

Units Affected

2340 units, *amended to include additional 250 units