medical Class II Updated 2021-02-17

Aomori Olympus Co., Ltd. recalls B7-2Q BALLOON CATHETER 13MM DIA 3.2, model no. B7-2Q -Produc

Recalled Product

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


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, 02K, 03K, 06K, 07K, 08K, 98K, 99K, 9XK, 9YK, 9ZK
View official government recall

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