Recall Z-1085-03 ยท BSY Catheters, Suction, Tracheobronchial
Ballard Medical Products
Kimberly-Clark / Ballard TRACH-CARE* MAC (Multi Access Catheter) for Neonates. For distribution to Germany only.
| Date | Aug 6, 2003 (initiated Jun 13, 2003) |
| Status | Terminated |
| 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 | 425 units |
| Distribution | Nationwide and to Belgium, Canada, Colombia, Germany, Japan, Norway, South Africa, Sweden, Switzerland, Turkey, United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.