Reported May 22, 2013 · Terminated
INSTAT - Agent, Absorbable Hemostatic, Collagen Based INSTAT MCH is recommended for use in surgical procedures (other…
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?
- INSTAT - Agent, Absorbable Hemostatic, Collagen Based INSTAT MCH is recommended for use in surgical procedures (other than Urological and Ophthalmological surgery) as an adjunct to hemostatis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
- Lot codes and dates
11051771105178 11101431110227 11102281110229 11102301110233 11107861110787 11113561105179 111023 11110232 1110785
- Amount recalled
- 17, 616 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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