IBC Aortic Punch Catalog Numbers APM40, APL48A, APM44A, APL40A, APM40A, CVAPL36, CVAPL40, CVAPL44, CVAPL48, CVAPL52, APM
FDA device recall Z-2423-2015 · posted 2015-08-19 · Terminated
Recall details
- Recalling firm
- International Biophysics Corp.
- Reason for recall
- It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria.
- Action taken
- The recalling firm began notifying their affacted customers on 7/2/2015
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- DWS
- Quantity affected
- 10,330 units
- Distribution
- Worldwide - United States Nationwide and the countries of: Germany, Norway, Turkey, Chile, Pakistan, and Republic of South Africa
- Date initiated
- 2015-08-07
- Date posted
- 2015-08-19
- Date terminated
- 2016-03-01
- Location
- Austin, TX
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