FDA Medical Device Recalls (openFDA)
Ballard Medical Products: Kimberly-Clark / Ballard TRACH-CARE* MAC (Multi Access Catheter) for Neonates
- Recall number
- Z-1083-03
- Recalling firm
- Ballard Medical Products
- Product
- Kimberly-Clark / Ballard TRACH-CARE* MAC (Multi Access Catheter) for Neonates
- Status
- Terminated
- Initiated
- 2003-06-13
- Posted
- 2003-08-06
- Terminated
- 2003-11-24
- Reason
- Incorrect plug was included in the multi access catheter pkg. When inserted in the 'Y' it may disengage, allowing a leak of ventilator gases.
- Root cause
- Other
- Action
- All consignees were notified by letter on 06/13/2003.
- Quantity
- 500 units
- Distribution
- Nationwide and to Belgium, Canada, Colombia, Germany, Japan, Norway, South Africa, Sweden, Switzerland, Turkey, United Kingdom.
- Lot, serial or model codes
- Catalog No: 1935, Lot Numbers: 212811
- 510(k) numbers
- ["K872621"]
- PMA numbers
- not on file
- Product code
- BSY
- Firm FEI
- 1719891
- Firm city
- Draper
- 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