Reported Aug 26, 2015 · Terminated
IBC Aortic Punch Catalog Numbers APM40, APL48A, APM44A, APL40A, APM40A, CVAPL36, CVAPL40, CVAPL44, CVAPL48, CVAPL52,…
International Biophysics Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: International Biophysics Corp. · Bldg 2, Ste 275 · Austin, TX · 78744-1015
Is this the product you have?
IBC Aortic Punch Catalog Numbers APM40APL48AAPM44AAPL40AAPM40ACVAPL36CVAPL40CVAPL44CVAPL48CVAPL52APM28BMAPM36BMAPM40BMAPM44BMAPM48BMAPM40BKAPM48BKAPM36BKAPM44BKAPM28APM36APL44
- APM40 Product UsageThe 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
- Lot codes and dates
042415-3488022515-337202215-3374022515-3372022515-3371022515-3373022515-3382022515-3383022515-3384022515-3385022515-3386040615-3452040615-3453040615-3449040615-3450040615-3451040615-3448040615-3447050815-3510050815-3509050815-3511050815-3512052715-3602060315-3603031215-3412022515-3387022515-3388033015-3442042415-3488
- Amount recalled
- 10,330 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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