Recall Z-2052-2018— Hobbs Medical, Inc.

Name: FDA recall Z-2052-2018
Creator: U.S. Food and Drug Administration
Published: 2018-05-01

Class II · Terminated

Class II FDA medical device recall by Hobbs Medical, Inc., initiated 2018-05-01, terminated 2020-04-10. It names one FDA 510(k) clearance: K834402. Product: Hobbs Bronchial Cytology Brushes, Model Number 4202; 4204; 4206 To be utilized by a trained physician and/or trained personnel through a flexible endoscope when brush cell samples are required for cytological analysis.. Reason: Device was marketed for uses outside the 510(k) clearance..

Recalling firm: Hobbs Medical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-05-01
Terminated: 2020-04-10
Firm location: Stafford Springs, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K834402 — GASTROINTESTINAL SHEATH BRUSHHobbs Medical, Inc.·cleared 1984-02-04

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

Hobbs Bronchial Cytology Brushes, Model Number 4202; 4204; 4206 To be utilized by a trained physician and/or trained personnel through a flexible endoscope when brush cell samples are required for cytological analysis.

Reason for recall

Device was marketed for uses outside the 510(k) clearance.

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