Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0964-2021 — 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.

U.S. FDA — Device Enforcement · Japan · 2021-01-04 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0964-2021
Date of alert: 2021-01-04
Country / jurisdiction: Japan
Risk level: Class II
Risk type: recall
Brand: Aomori Olympus Co., Ltd.
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-0964-2021 — 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.

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