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U.S. Department of Health and Human Services

Class 2 Device Recall Hobbs Medical Polypectomy Snare

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  Class 2 Device Recall Hobbs Medical Polypectomy Snare see related information
Date Initiated by Firm June 03, 2022
Create Date July 15, 2022
Recall Status1 Open3, Classified
Recall Number Z-1388-2022
Recall Event ID 90456
510(K)Number K844074  
Product Classification Endoscopic grasping/cutting instrument, non-powered - Product Code OCZ
Product Hobbs Medical Polypectomy Snare, Catalog No. 7202
Code Information UDI-DI: M84972020 Package UDI: M84972021 Lots: H11-20-017 H04-20-062 H04-19-056 H11-19-077 H08-17-014R H10-17-089R H10-17-089 H0S-17-014 H06-17-167
Recalling Firm/
Manufacturer		 Hobbs Medical, Inc.
8 Spring St
Stafford Springs CT 06076-1505
For Additional Information Contact Hobbs Medical Customer Service
800-344-6227
Manufacturer Reason
for Recall		 During use, the sheath of the device may accordion at the proximal end where the sheath meets the shrink band. Kinking of the sheath may prevent the snare from fully closing, and injury may result.
FDA Determined
Cause 2		 Component design/selection
Action On June 3, 2022, the firm distributed Urgent Medical Device Recall letters to affected customers. Customers were instructed to immediately cease use of the affected product and to return the product to Hobbs Medical. For questions related to the Acknowledgement Form and its return, please contact Hobbs Customer Service at 1-800-344-6227
Quantity in Commerce 45 (US)
Distribution Domestic distribution to NC, TX, and WA. Foreign distribution to Canada.
Total Product Life Cycle TPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = OCZ and Original Applicant = HOBBS MEDICAL, INC.
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