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| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1388-2022 | Class II | Ongoing | Voluntary: Firm initiated |
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