Boston Scientific brand Standard PEG (percutaneous endoscopic gastrostomy tubes) Kit, 24 Fr, pull; catalog number 6824.
FDA Recall Z-0965-05 · Posted 2005-07-07
Recalling FirmBoston Scientific Corp
Recall StatusTerminated
Product CodeKGC
Date Initiated2005-06-02
Date Terminated2006-12-13
Reason for Recall
Two blades may be heat staked onto the stiletto instead of the expected one blade.
Firm Action
Customers were notified by a recall letter dated 6/7/05 which instructed them to return any of the recalled products on hand.
Root Cause
Other
Distribution Pattern
Nationwide and Panama.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.