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Recall Observatory FDA recall evidence

Device 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.

Z-0968-2021

January 04, 2021

Class II

Product summary

Firm
Aomori Olympus Co., Ltd.
Event
Event 87074
Status
Terminated
Classification
Class II
Quantity
7,400,000 (global); 260,395 (US)
Official record key
device-enforcement:Z-0968-2021

Official wording

Reason: 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.

Code information: 06V, 07V, 08V, 09V, 0XV

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    inadequate package
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    sterile packages with inadequate