Reported Aug 26, 2015 · Terminated
IBC Vascular Loop Catalog Number CH111, CH112, CH113, CH114, CH115, CH116, CH118 Product Usage: The IBC Vascular Loop…
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 Vascular Loop Catalog Number CH111CH112CH113CH114CH115CH116
- CH118 Product UsageThe IBC Vascular Loop is a single-use, disposable loop used in occluding, retracting, and identifying arteries, veins, tendons, and nerves in surgical procedures
- Lot codes and dates
031715-3418050815-3513052115-3540033015-3435052115-3542031615-3417050815-3514052115-3543033015-3436050815-3515060915-3578041715-3478033015-3437050815-3516052215-3545042015-3482052115-3541
- Amount recalled
- 771 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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