Recall Z-0760-2022— Boston Scientific Corporation

Name: FDA recall Z-0760-2022
Creator: U.S. Food and Drug Administration
Published: 2021-12-22

Class II · Ongoing

Class II FDA medical device recall by Boston Scientific Corporation, initiated 2021-12-22. It names one FDA 510(k) clearance: K013153. Product: HYDRATOME RX 44-20MM/450CM Material Number: M00583060. Reason: Sterility of device is compromised due to a sterile barrier breach.

Recalling firm: Boston Scientific Corporation
Classification: Class II
Status: Ongoing
Initiated: 2021-12-22
Firm location: Marlborough, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K013153 — AUTOTOME RX MODEL # 4515, 4516Boston Scientific Corp·cleared 2001-10-19

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

HYDRATOME RX 44-20MM/450CM Material Number: M00583060

Reason for recall

Sterility of device is compromised due to a sterile barrier breach

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