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

Recall Z-0877-2017 — BD SurePathTM Preservative Collection Vials, catalog numbers 490505, 490527, 491095, 491096, and 491097. SurePath¿ Preservative Fluid is designed for use with the PrepStain¿ System. SurePath¿ Preservative Fluid is an alcohol-based, preservation solution that serves as a transport, preservative a

U.S. FDA — Device Enforcement · United States · 2016-02-12 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0877-2017
Date of alert: 2016-02-12
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Becton Dickinson & Co.
Product category: device
Product type: Devices

Reported risk: BD has confirmed that a portion of BD SurePath" collection vials associated with specific production lots may contain caps that are cracked which can lead to leaking of the preservative fluid.

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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