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Proxima Sterile, Disposable Set Up Pack III, Reorder DYNJP1047; a sterilized convenience kit for surgical procedures com

FDA device recall Z-0777-06 · posted 2006-04-19 · Terminated

Recall details

Recalling firm
Medline Industries, Inc.
Reason for recall
The product may not be sterile. The pouches were damaged during sterilization.
Action taken
The direct account hospital was visited by a Medline sales representative on 3/30/06, and the affected product was retrieved and returned to Medline.
Root cause
Other
Status
Terminated
Product code
LRO
Quantity affected
21 cases
Distribution
Texas
Date initiated
2006-03-30
Date posted
2006-04-19
Date terminated
2006-05-09
Location
Waukegan, IL

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