Recall Z-2423-2015— International Biophysics Corp.
Class II · Terminated
Class II FDA medical device recall by International Biophysics Corp., initiated 2015-08-07, terminated 2016-03-01. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria..
- Recalling firm
- International Biophysics Corp.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-08-07
- Terminated
- 2016-03-01
- Firm location
- Austin, TX, United States
Product description
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.
Reason for recall
It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria.
Data sourced from openFDA. This site is unofficial and independent of the FDA.