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U.S. Department of Health and Human Services

Class 2 Device Recall Hobbs Bronchial Cytology Brushes

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 Class 2 Device Recall Hobbs Bronchial Cytology Brushessee related information
Date Initiated by FirmMay 01, 2018
Create DateJune 01, 2018
Recall Status1 Terminated 3 on April 10, 2020
Recall NumberZ-2052-2018
Recall Event ID 79903
510(K)NumberK834402 
Product Classification endoscopic cytology brush - Product Code FDX
ProductHobbs 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.
Code Information H07-17-157 H12-17-004 H10-17-055 H12-17-062 H11-17-101 H12-17-062 H11-17-119 H12-17-064 H11-17-120 H12-17-064 H11-17-121 H12-17-065 H11-17-122 H12-17-066 H11-17-123 H12-17-067 H11-17-124 H01-18-095 H11-17-125 H01-18-096 H11-17-126 H01-18-097 H11-17-127 H01-18-097 H11-17-128 H01-18-098 H11-17-129 H01-18-098 H11-17-130 H01-18-098 H12-17-002 H01-18-099 H12-17-003 H01-18-100 H12-17-003 H01-18-101 H01-18-102
Recalling Firm/
Manufacturer		 Hobbs Medical, Inc.
8 Spring St
Stafford Springs CT 06076-1505
For Additional Information ContactCraig Cheyne
860-851-9845
Manufacturer Reason
for Recall		Device was marketed for uses outside the 510(k) clearance.
FDA Determined
Cause 2		Labeling False and Misleading
ActionThe firm, Hobbs Medical, Inc., sent an "Voluntary Medical Device Recall Advisory Notice" letter to customers on 5/1/18. The letter described the product, problem and actions to be taken. Our records indicate that you have received the following Bronchial Cytology Brushes since the beginning of 2018: Please complete the quantity used and quantity returned section of the attached form and you may voluntarily return any unused device(s) referencing Return Authorization Number. Hobbs Medical will credit your account in a timely fashion. f you have any questions, please contact customer service at 800-344-6227.
Quantity in Commerce1820 devices
DistributionUS Nationwide Distribution to states of: AZ, CA, GA, IL, MD, NY, TN, TX, and VA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = FDX
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