Recall Z-1017-2022— Freudenberg Medical, Llc

Name: FDA recall Z-1017-2022
Creator: U.S. Food and Drug Administration
Published: 2022-02-21

Class II · Terminated

Class II FDA medical device recall by Freudenberg Medical, Llc, initiated 2022-02-21, terminated 2024-04-18. It names one FDA 510(k) clearance: K190628. Product: Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-200 (OUS). Reason: Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemia.

Recalling firm: Freudenberg Medical, Llc
Classification: Class II
Status: Terminated
Initiated: 2022-02-21
Terminated: 2024-04-18
Firm location: Jeffersonville, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K190628 — FlexSeal Introducer Sheath with Hydrophilic CoatingFreudenberg Medical Mis, Inc.·cleared 2019-05-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-200 (OUS)

Reason for recall

Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemia

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