Z-0842-04

Product in clear plastic pouch labeled: Boston Scientific MEDI-TECH * VASCULAR DILATOR * Order No./REF...

Name: Z-0842-04 Product in clear plastic pouch labeled: Boston Scientific MEDI-TECH *** VASCULAR DILATOR *** Order No./REF...
Creator: Boston Scientific Corp
Published: 2004-03-18
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2004-03-18 / Terminated / root cause: labeling and UDI

FDA source

Boston Scientific Corp began a recall of Product in clear plastic pouch labeled: Boston Scientific MEDI-TECH *** VASCULAR DILATOR *** Order No./REF: 48-151 M001481510, 5 Fr. Firm on the label: Boston... on 2004-03-18. The reason FDA records is "Product labeled at Vascular Dilator Set 5 Fr contains 5 dilators ranging from 6 Fr to 14 Fr". 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-0842-04
Status: Terminated
Initiated: 2004-03-18
Posted: 2004-07-20
Terminated: 2005-10-25
Recalling firm: Boston Scientific Corporation
Product: Product in clear plastic pouch labeled: Boston Scientific MEDI-TECH *** VASCULAR DILATOR *** Order No./REF: 48-151 M001481510, 5 Fr. Firm on the label: Boston Scientific Corporation, 480 Pleasant Street, Watertown, MA 02472.
Product code: DRE Dilator, Vessel, For Percutaneous Catheterization
Reason for recall: Product labeled at Vascular Dilator Set 5 Fr contains 5 dilators ranging from 6 Fr to 14 Fr.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Letter dated 4/2/04 flagged as an addendum to a letter dated 3/18/04, with instructions to return product.
Quantity in commerce: 43 units
Distribution: Hospitals in CA, CT, FL, GA, IL, MI, NM, OH, WA, WI.
Product codes and lots: 929123, Exp. 12/2006

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)