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

Recall Z-3281-2018 — AXS Infinity LS Long Sheath:((6F/.088in)/ x 70cm GEN-10800-70, (6F/.088in)/ x 80cm GEN-10800-80, (6F/.088in)/ x 90cm GEN-10800-90) Made in Ireland, Sterile EO. The AXS Infinity LS Long Sheath system contents are: One (1) AXS Infinity LS Long Sheath, One (1) Hemostasis valve with extension tubing, O

U.S. FDA — Device Enforcement · United States · 2018-05-02 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-3281-2018
Date of alert: 2018-05-02
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Stryker Neurovascular
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 20156091

Reported risk: The AXS Infinity LS Long Sheath Dilator outer diameter (OD) specification was exceeded.

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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