Recall Z-2424-2015
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 Vascular Loop Catalog Number CH111, CH112, CH113, CH114, CH115, CH116, CH118 Product Usage: The IBC Vascular Loop is a single-use, disposable loop used in occluding, retracting, and identifying arteries, veins, tendons, and nerves in surgical procedures.
Codes / lots: 031715-3418, 050815-3513, 052115-3540, 033015-3435, 052115-3542, 031615-3417, 050815-3514, 052115-3543, 033015-3436, 050815-3515, 060915-3578, 041715-3478, 033015-3437, 050815-3516, 052215-3545, 042015-3482, 052115-3541
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-2424-2015
- Initiated
- August 7, 2015
- Posted by FDA
- August 19, 2015
- Terminated
- March 1, 2016
- Product code
- DWS – Instruments, Surgical, Cardiovascular
- Quantity
- 771 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-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 |