FDA Recall
Terminated
KimVent Closed Suction System for Adults, Double Swivel Elbow, 14 Fr. Sterile, Distributed by Kimberly Clark Global Systems, LLC.
Recall: Z-1221-2015
·
Initiated January 16, 2015
Recall
- Recall Number
- Z-1221-2015
- Event Number
- 70397
- Firm
- Halyard Health
- FEI Number
- 3011157493
- Product Code
- BSY
- Status
- Terminated
- Root Cause
- Packaging process control
- Initiated
- January 16, 2015
- Posted
- February 27, 2015
- Terminated
- July 7, 2015
- Address
- 1400 Holcomb Bridge Rd, Roswell, GA, 30076-2190
Description
KimVent Closed Suction System for Adults, Double Swivel Elbow, 14 Fr. Sterile, Distributed by Kimberly Clark Global Systems, LLC.
Reason
Defect: A hole or crack was found which may cause air to leak.
Action
Consignees were notified by letter via FedEx on 01/16/2015.
Distribution
CA, FL, IL, LA, MA, MK, MN, MS, NM, NY, OK and TX and Japan.
Quantity
5 cases (20 tubes per case)