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

Recall Z-2178-2018 — Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035 Product Usage: The Maquet Cardiopulmonary Bypass Custom Tubing kit is a sterile, non-pyrogenic device for single use only and is not to be re-sterilized by the user. The product consists of tubing and c

U.S. FDA — Device Enforcement · United States · 2017-07-27 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2178-2018
Date of alert: 2017-07-27
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Datascope Corporation
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 0607567204133

Reported risk: There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flow through.

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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