Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2957-2018 — 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***"."

U.S. FDA — Device Enforcement · United States · 2018-05-30 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2957-2018
Date of alert
2018-05-30
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Baxter Healthcare Corporation
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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