Reported May 22, 2013 · Terminated
Helitene Absorbable Collagen Hemostatic Sponge Helitene is indicated in surgical procedures (other than…
Integra LifeSciences Corporation
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: Integra LifeSciences Corporation · 105 Morgan Ln · Plainsboro, NJ · 08536-3339
Is this the product you have?
- Helitene Absorbable Collagen Hemostatic Sponge Helitene is indicated in surgical procedures (other than ophthalmological and urological surgery) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
- Lot codes and dates
11107881112217 11102221111357 11116021105255 11102241110225 11116011110223 11107901111603
- Amount recalled
- 14, 525 boxes
This recall covers 21 products
The agency filed one notice per product. You are reading one of them; the other 20 are below.
8 more are in the archive.
Where it was sold
- Nationwide
- PR
Why it was recalled
Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
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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