Z-1105-04

Boston Scientific/MEDI-TECH brand Fascial Dilator, 10 FR (3.3 mm), sterile, single use only, model...

Name: Z-1105-04 Boston Scientific/MEDI-TECH brand Fascial Dilator, 10 FR (3.3 mm), sterile, single use only, model...
Creator: Boston Scientific Corp
Published: 2004-06-16
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2004-06-16 / Terminated / root cause: labeling and UDI

FDA source

Boston Scientific Corp began a recall of Boston Scientific/MEDI-TECH brand Fascial Dilator, 10 FR (3.3 mm), sterile, single use only, model M001482501, REF/Catalog No. 48-250 on 2004-06-16. The reason FDA records is "Labeling mix-up as to product size; 8FR may be labeled 10FR and vice versa". 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-1105-04
Status: Terminated
Initiated: 2004-06-16
Posted: 2004-07-20
Terminated: 2005-02-11
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific/MEDI-TECH brand Fascial Dilator, 10 FR (3.3 mm), sterile, single use only, model M001482501, REF/Catalog No. 48-250.
Product code: DRE Dilator, Vessel, For Percutaneous Catheterization
Reason for recall: Labeling mix-up as to product size; 8FR may be labeled 10FR and vice versa.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Recall letters dated June 16, 2004 were sent to consignees requesting product return.
Quantity in commerce: 550
Distribution: Nationwide and Netherlands.
Product codes and lots: Lot 6015888.

Product code DRE

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)