FDA Medical Device Recalls (openFDA)
Becton Dickinson Medical Systems: 16 G / 5F Dual Lumen L-Cath Basic Kit with Introsyte
- Recall number
- Z-0285-06
- Recalling firm
- Becton Dickinson Medical Systems
- Product
- 16 G / 5F Dual Lumen L-Cath Basic Kit with Introsyte
- Status
- Terminated
- Initiated
- 2005-03-25
- Posted
- 2005-12-15
- Terminated
- 2011-08-08
- Reason
- Aspiration (blood return) could not be achieved on some L-Cath 16 gauge catheters.
- Root cause
- Other
- Action
- Consignees were notified via telephone and fax letter, beginning 04/25/2005.
- Quantity
- 5740 units
- Distribution
- AL, CA, CO, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, NJ, OH, OK, PA, TN, TX, WA. No Government or military consignees. Foreign distribution to Australia, Canada, Japan.
- Lot, serial or model codes
- REF 384426
- 510(k) numbers
- ["K920755"]
- PMA numbers
- not on file
- Product code
- LJS
- 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