| Class 2 Device Recall Aortic Punch | |
Date Initiated by Firm | August 07, 2015 |
Date Posted | August 19, 2015 |
Recall Status1 |
Terminated 3 on March 01, 2016 |
Recall Number | Z-2423-2015 |
Recall Event ID |
71911 |
Product Classification |
Instruments, surgical, cardiovascular - Product Code DWS
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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. |
Code Information |
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 |
Recalling Firm/ Manufacturer |
International Biophysics Corp. Bldg 2, Ste 275 2101 E Saint Elmo Rd Austin TX 78744-1015
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For Additional Information Contact | Geoff Marcek 512-814-0046 |
Manufacturer Reason for Recall | It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria. |
FDA Determined Cause 2 | Packaging process control |
Action | The recalling firm began notifying their affacted customers on 7/2/2015 |
Quantity in Commerce | 10,330 units |
Distribution | Worldwide - United States Nationwide and the countries of: Germany, Norway, Turkey, Chile, Pakistan, and Republic of South Africa |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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