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U.S. Department of Health and Human Services

Class 2 Device Recall Hobbs Medical

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  Class 2 Device Recall Hobbs Medical see related information
Date Initiated by Firm March 15, 2006
Date Posted May 03, 2006
Recall Status1 Terminated 3 on June 27, 2006
Recall Number Z-0824-06
Recall Event ID 35011
510(K)Number K833125  
Product Classification unknown device name - Product Code KOG
Product Hobbs Medical 3 Prong Looped Retriever, a disposable device to be used by physician to remove foreign object or cauterize polyp specimens from the GI tract.
REF: 5030 and 5030S
Code Information Lot Numbers: H11-05-040; H11-05-138; H11-05-139; H11-05-140;H11-05-141; H11-05-205.
Recalling Firm/
Manufacturer
Hobbs Medical, Inc.
8 Spring St
Stafford Springs CT 06076-1505
For Additional Information Contact Robert J. Coles
860-684-5875
Manufacturer Reason
for Recall
Diameter of device at the distal end would prevent it from passing through the endoscope's working channel.
FDA Determined
Cause 2
Process control
Action Hobbs Medical notfied customers by Registered Letter on 3/15/06, requesting return of recalled product.
Quantity in Commerce 254 units
Distribution AK, IA, KY, MI, NH, NC,UT, WI, Canada, and UK

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) Database 510(K)s with Product Code = KOG and Original Applicant = HOBBS MEDICAL, INC.
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