Z-2423-2015Class II

IBC Aortic Punch Catalog Numbers APM40, APL48A, APM44A, APL40A, APM40A, CVAPL36, CVAPL40, CVAPL44, CVAPL48...

Name: Z-2423-2015 IBC Aortic Punch Catalog Numbers APM40, APL48A, APM44A, APL40A, APM40A, CVAPL36, CVAPL40, CVAPL44, CVAPL48...
Creator: International Biophysics Corp.
Published: 2015-08-07
License: https://open.fda.gov/license/

International Biophysics Corp. / initiated 2015-08-07 / Terminated / root cause: packaging

FDA source

International Biophysics Corp. began a recall of IBC Aortic Punch Catalog Numbers APM40, APL48A, APM44A, APL40A, APM40A, CVAPL36, CVAPL40, CVAPL44, CVAPL48, CVAPL52, APM28BM, APM36BM, APM40BM, APM44BM... on 2015-08-07. FDA classified it as Class II and gives the reason as "It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2423-2015
Classification: Class II
Status: Terminated
Initiated: 2015-08-07
Posted: 2015-08-19
Terminated: 2016-03-01
Recalling firm: International Biophysics Corp.
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.
Product code: DWS Instruments, Surgical, Cardiovascular
Reason for recall: It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria.
Root cause tag: packaging
FDA root cause: 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
Product codes and 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2423-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2422-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-26	2015-08-19
Z-2423-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-26	2015-08-19
Z-2424-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-26	2015-08-19

Product code DWS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)