FDAMay 30, 2018device
FLOSEAL Special Applicator Tips in cartons labeled in part, "Floseal SPECIAL APPLICATOR TIPS***6 x Malleable Tip Trimmable Tip***Baxter***." The pouches inside the cartons are labeled in part, "Floseal SPECIAL APPLICATOR TIPS***Baxter***"."
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Baxter r recalled this device due to the use of an incorrect plastic formulation in the manufacture of the blue luer component of the FLOSEAL malleable tips.
What to do
FDA enforcement status: Ongoing
Brands named
baxter healthcarebaxter
Recall history
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