Recall Z-1388-2022— Hobbs Medical, Inc.

Name: FDA recall Z-1388-2022
Creator: U.S. Food and Drug Administration
Published: 2022-06-03

Class II · Ongoing

Class II FDA medical device recall by Hobbs Medical, Inc., initiated 2022-06-03. It names one FDA 510(k) clearance: K844074. Product: Hobbs Medical Polypectomy Snare, Catalog No. 7202. Reason: 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..

Recalling firm: Hobbs Medical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-06-03
Firm location: Stafford Springs, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K844074 — HOBBS MEDICAL POLYPECTOMY SNAREHobbs Medical, Inc.·cleared 1985-01-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.