FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: PASV PICC Catheter - 4.5 Fr Dual Lumen, Catalog #PIC402CKIR, Material Number M001PIC402CKIRO. Responsible firm on label: Boston Scientific *** Manufactured at: 10 Glens Falls Technical Park, Glens Falls, NY 12801 USA
- Recall number
- Z-1050-05
- Recalling firm
- Boston Scientific Corporation
- Product
- PASV PICC Catheter - 4.5 Fr Dual Lumen, Catalog #PIC402CKIR, Material Number M001PIC402CKIRO. Responsible firm on label: Boston Scientific *** Manufactured at: 10 Glens Falls Technical Park, Glens Falls, NY 12801 USA
- Status
- Terminated
- Initiated
- 2004-03-05
- Posted
- 2005-07-28
- Terminated
- 2006-02-06
- Reason
- Lumens may have incorrect lumen size marked on them.
- Root cause
- Other
- Action
- Letters dated March 5, 2004 with instructions to return product to Boston Scientific.
- Quantity
- 45 units
- Distribution
- Nationwide. Medical facilities in CA, GA, IA, IL, ME, MI, MO, NJ, OH, TN TX, UT, WI,
- Lot, serial or model codes
- 919488, 924206
- 510(k) numbers
- ["K963097"]
- PMA numbers
- not on file
- Product code
- LJS
- 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