Z-1084-03

Kimberly-Clark / Ballard TRACH-CARE* MAC (Multi Access Catheter) for Neonates. For international distribution...

Name: Z-1084-03 Kimberly-Clark / Ballard TRACH-CARE* MAC (Multi Access Catheter) for Neonates. For international distribution...
Creator: Ballard Medical Products
Published: 2003-06-13
License: https://open.fda.gov/license/

Ballard Medical Products / initiated 2003-06-13 / Terminated

FDA source

Ballard Medical Products began a recall of Kimberly-Clark / Ballard TRACH-CARE* MAC (Multi Access Catheter) for Neonates. For international distribution only on 2003-06-13. The reason FDA records is "Incorrect plug was included in the multi access catheter pkg. When inserted in the 'Y' it may disengage, allowing a leak of ventilator gases". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1084-03
Status: Terminated
Initiated: 2003-06-13
Posted: 2003-08-06
Terminated: 2003-11-24
Recalling firm: Ballard Medical Products
Product: Kimberly-Clark / Ballard TRACH-CARE* MAC (Multi Access Catheter) for Neonates. For international distribution only.
Product code: BSY Catheters, Suction, Tracheobronchial
Reason for recall: Incorrect plug was included in the multi access catheter pkg. When inserted in the 'Y' it may disengage, allowing a leak of ventilator gases.
FDA root cause: Other
Action: All consignees were notified by letter on 06/13/2003.
Quantity in commerce: 700 units
Distribution: Nationwide and to Belgium, Canada, Colombia, Germany, Japan, Norway, South Africa, Sweden, Switzerland, Turkey, United Kingdom.
Product codes and lots: Catalog No: 1900IN, Lot Numbers: 210293, 210296.

Product code BSY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)