Recall Z-0781-2022— Boston Scientific Corporation

Name: FDA recall Z-0781-2022
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: RX CHOLANGIOGRAM KIT - SINGLE Material Number: M00575240 M00575240 M00575280 M00575320 M00575360 M00575380 M00575400 M00575440 M00575480. 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

RX CHOLANGIOGRAM KIT - SINGLE Material Number: M00575240 M00575240 M00575280 M00575320 M00575360 M00575380 M00575400 M00575440 M00575480

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.