FDA recall Z-1388-2022

Hobbs Medical, Inc. · Class II · device

Product

Hobbs Medical Polypectomy Snare, Catalog No. 7202

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.

Distribution

Domestic distribution to NC, TX, and WA. Foreign distribution to Canada.

Key facts

Status
Ongoing
Initiation date
2022-06-03
Report date
2022-07-27
Voluntary/Mandated
Voluntary: Firm initiated
Location
Stafford Springs, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1388-2022