Device product
KimVent Closed Suction System for Adults, Double Swivel Elbow, 12 Fr., Sterile, Distributed by Kimberly Clark Global Systems, LLC.
Z-1220-2015
Product summary
- Firm
- Halyard Health
- Event
- Event 70397
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5 cases (20 tubes per case)
- Official record key
device-enforcement:Z-1220-2015
Official wording
Reason: Defect: A hole or crack was found which may cause air to leak.
Code information: Product Code; 2160, Lot number: M4132T636
Distribution pattern: CA, FL, IL, LA, MA, MK, MN, MS, NM, NY, OK and TX and Japan.
Derived failure modes
-
Unknown
Defect: A hole or crack was found which may cause air to leak.