Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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.

FDA Recall Z-2423-2015 · Posted 2015-08-19

Recalling FirmInternational Biophysics Corp.
Recall StatusTerminated
Product CodeDWS
Date Initiated2015-08-07
Date Terminated2016-03-01
Product Quantity10,330 units

Reason for Recall

It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria.

Firm Action

The recalling firm began notifying their affacted customers on 7/2/2015

Root Cause

Packaging process control

Distribution Pattern

Worldwide - United States Nationwide and the countries of: Germany, Norway, Turkey, Chile, Pakistan, and Republic of South Africa

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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