FDA Medical Device Recalls (openFDA)
Boston Scientific Corp: Boston Scientific/Microvasive brand Biliary Stent Kit, 7 FR x 5 cm, sterile, single use only; Ref 3101.
- Recall number
- Z-1102-04
- Recalling firm
- Boston Scientific Corp
- Product
- Boston Scientific/Microvasive brand Biliary Stent Kit, 7 FR x 5 cm, sterile, single use only; Ref 3101.
- Status
- Terminated
- Initiated
- 2004-06-18
- Posted
- 2004-07-20
- Terminated
- 2004-12-14
- Reason
- Mislabeled as to length; 10 cm length labeled as 5 cm.
- 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.
- Quantity
- not on file
- Distribution
- California, Hawaii, Kentucky, New Jersey and Oregon.
- Lot, serial or model codes
- Lot 6419084.
- 510(k) numbers
- ["K834468"]
- PMA numbers
- not on file
- Product code
- FGE
- Firm FEI
- 1828132
- Firm city
- Spencer
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28