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

Recall Z-1941-2015 — Extractor Pro RX Retrieval Balloon Catheter 9-12 mm Above Retrieval Balloon Catheter; Universal Product Number (UPN) M00547000 The Extractor Pro RX Retrieval Balloon Catheters are intended for use endoscopically to remove stones from the biliary system, or to facilitate injection of contrast medium

U.S. FDA — Device Enforcement · United States · 2015-04-27 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1941-2015
Date of alert: 2015-04-27
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Boston Scientific Corporation
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 17673858

Reported risk: One lot of the Extractor" Pro RX Retrieval Balloon Catheter (9-12mm balloon) contains an incorrect syringe size (12-15mm), which is larger than the size identified on the label.

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.

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