Recall Z-2423-2015
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 Aortic Punch Catalog Numbers APM40, APL48A, APM44A, APL40A, APM40A, CVAPL36, CVAPL40, CVAPL44, CVAPL48, CVAPL52, APM28BM, APM36BM, APM40BM, APM44BM, APM48BM, APM40BK, APM48BK, APM36BK, APM44BK, APM28, APM36, APL44, APM40 Product Usage: The IBC Aortic Punch is a single-use, disposable surgical punch used to create an opening in the wall of the aorta to prepare a site for anastomosis.
Codes / lots: 042415-3488, 022515-3372, 02215-3374, 022515-3372, 022515-3371, 022515-3373, 022515-3382, 022515-3383, 022515-3384, 022515-3385, 022515-3386, 040615-3452, 040615-3453, 040615-3449, 040615-3450, 040615-3451, 040615-3448, 040615-3447, 050815-3510, 050815-3509, 050815-3511, 050815-3512, 052715-3602, 060315-3603, 031215-3412, 022515-3387, 022515-3388, 033015-3442, 042415-3488
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-2423-2015
- Initiated
- August 7, 2015
- Posted by FDA
- August 19, 2015
- Terminated
- March 1, 2016
- Product code
- DWS – Instruments, Surgical, Cardiovascular
- Quantity
- 10,330 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-2422-2015 Class II | IBC Suction Wand Catalog Number 1990S Product Usage: The IBC Suction Wand is a component…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 |