Z-0968-05

Boston Scientific brand pull Gastro-dome (percutaneous endoscopic gastrostomy tubes) Kit, 24 Frl; catalog...

Name: Z-0968-05 Boston Scientific brand pull Gastro-dome (percutaneous endoscopic gastrostomy tubes) Kit, 24 Frl; catalog...
Creator: Boston Scientific Corp
Published: 2005-06-02
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2005-06-02 / Terminated

FDA source

Boston Scientific Corp began a recall of Boston Scientific brand pull Gastro-dome (percutaneous endoscopic gastrostomy tubes) Kit, 24 Frl; catalog number 6839 on 2005-06-02. The reason FDA records is "Two blades may be heat staked onto the stiletto instead of the expected one blade". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0968-05
Status: Terminated
Initiated: 2005-06-02
Posted: 2005-07-07
Terminated: 2006-12-13
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific brand pull Gastro-dome (percutaneous endoscopic gastrostomy tubes) Kit, 24 Frl; catalog number 6839.
Product code: KNT Tubes, Gastrointestinal (And Accessories)
Reason for recall: Two blades may be heat staked onto the stiletto instead of the expected one blade.
FDA root cause: Other
Action: Customers were notified by a recall letter dated 6/7/05 which instructed them to return any of the recalled products on hand.
Distribution: Nationwide and Panama.
Product codes and lots: Lots 7452728, 7442432, 7430336 and 7397622.

Product code KNT

K031538Class IIEndovive Initial Placement Peg Kit, Direct Pej Kit, and Peg Safety KitBoston Scientific Corp / cleared 2003-06-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)