Device product
KimVent Wet Pak, Closed Suction System for Adults, Double Swivel Elbow, 14 Fr. Sterile, Distributed by Kimberly Clark Global Systems, LLC.
Z-1222-2015
Product summary
- Firm
- Halyard Health
- Event
- Event 70397
- Status
- Terminated
- Classification
- Class II
- Quantity
- 83 cases (20 tubes per case)
- Official record key
device-enforcement:Z-1222-2015
Official wording
Reason: Defect: A hole or crack was found which may cause air to leak.
Code information: Product Code; 22108147, Wet Pak Lot number: AB4195U14, AB4216U06 & AB4230U16, KimVent Lot Number: M4132T643.
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.