medical Class II Updated 2018-09-05

Baxter Healthcare Corporation recalls FLOSEAL Special Applicator Tips in cartons labeled in part,

Recalled Product

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***"."

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Product Code: 1502186; Box Lot Numbers: HA170718, HA170818, and HA170917; Pouch Lot Numbers: GR338160 and GR338384
View official government recall

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