medical Class II Updated 2021-02-17

Aomori Olympus Co., Ltd. recalls B5-2Q BALLOON CATHETER, Model No. B5-2Q - Product Usage: Use

Recalled Product

B5-2Q BALLOON CATHETER, Model No. B5-2Q - Product Usage: Used with endoscopes to inject contrast medium or other medical fluid into the bile duct, pancreatic duct, and respiratory organs.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 01K, 03K, 04K, 06K, 07K, 08K, 09K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK
View official government recall

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