Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1388-2022Class II

Hobbs Medical Polypectomy Snare, Catalog No. 7202

Hobbs Medical, Inc. / initiated 2022-06-03 / Open, Classified / root cause: design

Hobbs Medical, Inc. began a recall of Hobbs Medical Polypectomy Snare, Catalog No. 7202 on . FDA classified it as Class II and gives the reason as "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". As of , the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number
Z-1388-2022
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
Hobbs Medical, Inc.
Product
Hobbs Medical Polypectomy Snare, Catalog No. 7202
Product code
OCZ Endoscopic Grasping/Cutting Instrument, Non-Powered
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.
Root cause tag
design
FDA root cause
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.
Product codes and lots
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

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1388-2022
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1388-2022Class IIOngoingVoluntary: Firm initiated