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

Recall Z-0075-2018 — HARVEST TERUMOBCT, GCP-10 Graft Delivery Pack, REF 51449, Rx Only, STERILE EO Harvest Graph Delivery System is a disposable pack that takes the cell concentrate created while using the BMAC Procedure Packs and allows for hydration of bone graft material for application to the sites doctors deem nec

U.S. FDA — Device Enforcement · United States · 2017-10-20 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0075-2018
Date of alert: 2017-10-20
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Terumo BCT, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 35020583514493

Reported risk: Certain lots of the Harvest Graft Delivery System GDP-10 Procedure Packs may have a lack of a seal on the inner pouch.

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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