Recall Z-2422-2015
International Biophysics Corp. · initiated August 7, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 033115-3445
Reason for recall
It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria.
FDA-determined cause: Packaging process control
Action taken
The recalling firm began notifying their affacted customers on 7/2/2015
Details
- Recall number
- Z-2422-2015
- Initiated
- August 7, 2015
- Posted by FDA
- August 19, 2015
- Terminated
- March 1, 2016
- Product code
- DTS – Sucker, Cardiotomy Return, Cardiopulmonary Bypass
- Quantity
- 100 units
- Distribution
- Worldwide - United States Nationwide and the countries of: Germany, Norway, Turkey, Chile, Pakistan, and Republic of South Africa
- Recalling firm
- International Biophysics Corp., Austin, TX
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2423-2015 Class II | IBC Aortic Punch Catalog Numbers APM40, APL48A, APM44A, APL40A, APM40A, CVAPL36…It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria. | 08/07/2015Terminated |
| Z-2424-2015 Class II | IBC Vascular Loop Catalog Number CH111, CH112, CH113, CH114, CH115, CH116, CH118 Product…It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria. | 08/07/2015Terminated |