Device product
IBC Suction Wand Catalog Number 1990S Product Usage: The IBC Suction Wand is a component of Blood Recovery System for use in open heart procedures, autologous blood recovery and blood suction. It is a disposable, single use component.
Z-2422-2015
Product summary
- Event
- Event 71911
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 units
- Official record key
device-enforcement:Z-2422-2015
Official wording
Reason: It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria.
Code information: 033115-3445
Distribution pattern: Worldwide - United States Nationwide and the countries of: Germany, Norway, Turkey, Chile, Pakistan, and Republic of South Africa
Derived failure modes
-
Unknown
It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria.