Reported Jun 8, 2016 · Terminated
COSEAL Surgical Sealant Kit, 8 mL, Product Code: 934072; For use in vascular reconstructions to achieve adjunctive…
Baxter Healthcare 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: Baxter Healthcare Corp · 21026 Alexander Ct · Hayward, CA · 94545-1234
Is this the product you have?
- COSEAL Surgical Sealant Kit, 8 mL
- Product Code934072; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage
- Lot codes and dates
HA151038HA151220HA151037HA151028HA160114HA160115HA160222
- Amount recalled
- 6,128 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
- PR
Why it was recalled
Potential for incomplete dissolution of the polyethylene glycol (PEG) component during the reconstitution of the product, which may affect the consistency of the hydrogel formation during use.
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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