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

Recall Z-1749-2013 — Edwards Lifesciences Suction Wand, models S099 and S0998B Suction wands are intended for hand held use and pericardial sumps are intended for stationary use in removing excess fluid from the surgical field.

U.S. FDA — Device Enforcement · United States · 2013-06-19 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1749-2013
Date of alert: 2013-06-19
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Edwards Lifesciences, LLC
Product category: device
Product type: Devices

Reported risk: Edwards is recalling certain lots of Rigid Suction Wands because they discovered plastic particulate inside the sterile pouch and within the internal diam ether of the wand.

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.

Recall Z-1749-2013 — Edwards Lifesciences Suction Wand, models S099 and S0998B Suction wands are intended for hand held use and pericardial sumps are intended for stationary use in removing excess fluid from the surgical field.

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