FDA Medical Device Recalls (openFDA)
Becton Dickinson Infusion Therapy: BD Introsyte-N Precision Introducer in 1.9Fr. Bulk, Non-sterile.
- Recall number
- Z-0587-04
- Recalling firm
- Becton Dickinson Infusion Therapy
- Product
- BD Introsyte-N Precision Introducer in 1.9Fr. Bulk, Non-sterile.
- Status
- Terminated
- Initiated
- 2004-02-03
- Posted
- 2004-07-20
- Terminated
- 2004-06-10
- Reason
- Splittable catheter introducer may not fully split or may separate non-uniformly.
- Root cause
- Other
- Action
- On 02/03/2004, all consignees were notified by telephone and letter.
- Quantity
- 12000 units
- Distribution
- Nationwide. Foreign distribution to Australia and Brazil. No government or military direct accounts.
- Lot, serial or model codes
- Catalog Number 380402, Lot Numbers 3356877, 3356485, 3352218.
- 510(k) numbers
- ["K974764"]
- PMA numbers
- not on file
- Product code
- FOZ
- Firm FEI
- 1710034
- Firm city
- Sandy
- Firm state
- UT
- 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