Recall Z-2957-2018— Baxter Healthcare Corporation

Name: FDA recall Z-2957-2018
Creator: U.S. Food and Drug Administration
Published: 2018-05-30

Class II · Ongoing

Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2018-05-30. FDA's recall record names no specific 510(k) clearance for this event. 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***".". Reason: 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..

Recalling firm: Baxter Healthcare Corporation
Classification: Class II
Status: Ongoing
Initiated: 2018-05-30
Firm location: Deerfield, IL, United States

Product description

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***"."

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.