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

Recall Z-0678-2017 — OnControl Biopsy System Ported Needle Tray, Sterile, Rx only, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adult and pediatric patients. The Arrow OnControl Bone Marrow Biopsy System is intended for bone marrow core biopsy of the ante

U.S. FDA — Device Enforcement · United States · 2016-11-08 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0678-2017
Date of alert: 2016-11-08
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Teleflex Medical
Product category: device
Product type: Devices

Reported risk: Sterility: Due to a potential incomplete seal on the outer sterile package.

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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