Z-1102-04

Boston Scientific/Microvasive brand Biliary Stent Kit, 7 FR x 5 cm, sterile, single use only; Ref 3101

Name: Z-1102-04 Boston Scientific/Microvasive brand Biliary Stent Kit, 7 FR x 5 cm, sterile, single use only; Ref 3101
Creator: Boston Scientific Corp
Published: 2004-06-18
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2004-06-18 / Terminated / root cause: labeling and UDI

FDA source

Boston Scientific Corp began a recall of Boston Scientific/Microvasive brand Biliary Stent Kit, 7 FR x 5 cm, sterile, single use only; Ref 3101 on 2004-06-18. The reason FDA records is "Mislabeled as to length; 10 cm length labeled as 5 cm". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1102-04
Status: Terminated
Initiated: 2004-06-18
Posted: 2004-07-20
Terminated: 2004-12-14
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific/Microvasive brand Biliary Stent Kit, 7 FR x 5 cm, sterile, single use only; Ref 3101.
Product code: FGE Stents, Drains And Dilators For The Biliary Ducts
Reason for recall: Mislabeled as to length; 10 cm length labeled as 5 cm.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Consignees were notified via recall letter dated June 18, 2004. Consignees were instructed to call the firm if they had any product in stock.
Distribution: California, Hawaii, Kentucky, New Jersey and Oregon.
Product codes and lots: Lot 6419084.

Product code FGE

K834468Class IIDrainage StentMicrovasive / cleared 1984-04-20

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)