FDA recall Z-0968-2021

Product

B-V443Q-A 3-LUMEN EXTRACTION BALLOON V, model no. B-V443Q-A - Product Usage: Used with endoscopes to endoscopically remove stones such as calculi, pancreatic and common bile duct stones.

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Distribution

US Nationwide distribution.

Key facts

Status

Terminated

Initiation date

2021-01-04

Report date

2021-02-17

Termination date

2024-03-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Kuroishi, N/A, Japan

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0968-2021