Home / Recalls / Aomori Olympus Co., Ltd. / Z-0964-2021

Z-0964-2021 Class II Terminated

Recalled by Aomori Olympus Co., Ltd. — Kuroishi, N/A

Recall Details

Product Type
Devices
Report Date
February 17, 2021
Initiation Date
January 4, 2021
Termination Date
March 11, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
7,400,000 (global); 260,395 (US)

Product Description

B7-2LA BALLOON CATHETER 13MM DIA 3.2, model no. B7-2LA - Product Usage: Used with endoscopes for injection of contrast medium or other medical fluid into the biliary or pancreatic tract.

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 Pattern

US Nationwide distribution.

Code Information

01K, 02K, 03K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK

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