Recall Z-1388-2022
Hobbs Medical, Inc. · initiated June 3, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Hobbs Medical Polypectomy Snare, Catalog No. 7202
Codes / 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
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: Component design/selection
Action taken
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
Details
- Recall number
- Z-1388-2022
- Initiated
- June 3, 2022
- Product code
- OCZ – Endoscopic Grasping/Cutting Instrument, Non-Powered
- Quantity
- 45 (US)
- Distribution
- Domestic distribution to NC, TX, and WA. Foreign distribution to Canada.
- Recalling firm
- Hobbs Medical, Inc., Stafford Springs, CT