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

Recall Z-0779-2019 — Cell Saver Elite Processing Kit, 70 ml, Product ID: CSE-P-70 Indications for Use: The Haemonetics Cell Saver 5/5+ System and its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.

U.S. FDA — Device Enforcement · United States · 2017-08-02 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0779-2019
Date of alert: 2017-08-02
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Haemonetics Corporation
Product category: device
Product type: Devices

Reported risk: Haemonetics has received isolated reports that in some cases the 70ml centrifuge bowl may leak during cell salvage processing.

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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