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

Recall Z-3035-2018 — Boston Scientific Wallstent Endoprosthesis Tracheobronchial Transhepatic Biliary Self-Expanding Stent, 12MM X 90MM | 75CM L, resterilized.

U.S. FDA — Device Enforcement · United States · 2018-03-07 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-3035-2018
Date of alert: 2018-03-07
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: SPS Sterilization, Inc
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 18030192

Reported risk: The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.

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

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Recall Z-3035-2018 — Boston Scientific Wallstent Endoprosthesis Tracheobronchial Transhepatic Biliary Self-Expanding Stent, 12MM X 90MM | 75CM L, resterilized.

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