FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: ASAP Channel Cut Biopsy System, 14 gauge Reference Number: 1250
- Recall number
- Z-1061-03
- Recalling firm
- Boston Scientific Corporation
- Product
- ASAP Channel Cut Biopsy System, 14 gauge Reference Number: 1250
- Status
- Terminated
- Initiated
- 2003-07-03
- Posted
- 2003-07-29
- Terminated
- 2004-06-17
- Reason
- Sterility of the device may be compromised due to a lack of package integrity
- Root cause
- Other
- Action
- Boston Scientific notified accounts by letter on 7/3/03. Accounts are requested to check inventory and return product. A Veification Form was requested to be completed.
- Quantity
- 1,030 units
- Distribution
- Nationwide
- Lot, serial or model codes
- 4104836, 4145036, 4211323, 4290090 ,4370503 4405122, 4445839, 4461241, 4569317, 4666229 4916051, 5022356, 5120746, 5133248, 5251508, 5288530
- 510(k) numbers
- ["K935814"]
- PMA numbers
- not on file
- Product code
- KNW
- Firm FEI
- 3001451463
- Firm city
- Natick
- Firm state
- MA
- 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