Atlas FDA

Endocoupler, C-Mount 30 mm Focal Length Catalog Number: 7204823, 7204823S

FDA device recall Z-0704-04 · posted 2004-07-20 · Terminated

Recall details

Recalling firm
Smith And Nephew, Inc. Endoscopy Division
Reason for recall
Endocouplers assembled with screws that cannot be effectively sterilized
Action taken
Smith & Nephew notified customers and sales rep. by letter dated 2/19/04. Sales reps will retrieve product and replace effected units in the field.
Root cause
Other
Status
Terminated
Product code
FXM
Quantity affected
28 units
Distribution
AL, AZ, CA, CT, PA, MA, ME, MI, MO, NC, NH, NJ, NY, OH, UT , TN, TX, VT, WA Foreiing:Australia, Canada, China, Brazil, France, Germany, Greece, India, Italy, Japan.Korea, Netherlands, Norway, Portugal
Date initiated
2004-02-19
Date posted
2004-07-20
Date terminated
2006-06-28
Location
Andover, MA

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