Recall Z-1220-2015 ยท BSY Catheters, Suction, Tracheobronchial
Halyard Health
KimVent Closed Suction System for Adults, Double Swivel Elbow, 12 Fr., Sterile, Distributed by Kimberly Clark Global Systems, LLC.
| Date | Feb 27, 2015 (initiated Jan 16, 2015) |
| Status | Terminated |
| Reason | Defect: A hole or crack was found which may cause air to leak. |
| Root cause | Packaging process control |
| Action | Consignees were notified by letter via FedEx on 01/16/2015. |
| Quantity | 5 cases (20 tubes per case) |
| Distribution | CA, FL, IL, LA, MA, MK, MN, MS, NM, NY, OK and TX and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.