FDA Device

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

Hazard

Incorrect plug was included in the multi access catheter pkg. When inserted in the 'Y' it may disengage, allowing a leak of ventilator gases.

What You Should Do

Remedy

All consignees were notified by letter on 06/13/2003.

Products

Kimberly-Clark / Ballard TRACH-CARE* MAC (Multi Access Catheter) for Neonates.
Brand
Ballard Medical Products
UPC
Catalog No: 1900, Lot Numbers:211006, 211830, 213674.

Units Affected

1565 units