Atlas FDA

TLC Self -Retaining Retractor System-Single Product Code: 820-175

FDA device recall Z-0257-06 · posted 2005-12-01 · Terminated

Recall details

Recalling firm
Boston Scientific Corporation
Reason for recall
Sterility of device compromised due to breach in packaging
Action taken
Boston Scientific initiated the recall on October 25, 2005 to accouunts requesting the return of the product and completion of the Reply Verification Tracking Form.
Root cause
Other
Status
Terminated
Product code
GAD
Quantity affected
5185
Distribution
Nationwide
Date initiated
2005-10-25
Date posted
2005-12-01
Date terminated
2007-06-20
Location
Natick, MA

Monitor recalls programmatically

Recalls and clearances share one API, with change alerts when new recalls post.