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

Recall Z-1516-2021 — ACE MDI Spacer with Small Mask - Product Usage: designed to assist with the delivery of aerosolized medications from metered dose inhaler canisters and with mechanically ventilated patients.

U.S. FDA — Device Enforcement · United States · 2021-03-31 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1516-2021
Date of alert: 2021-03-31
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Smiths Medical ASD Inc.
Product category: device
Product type: Devices

Reported risk: The firm became aware via complaints that one lot of ACE MDI Spacers with Small Masks and one lot of Palm Cups (Large) may have incorrect shipping box labels.

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-1516-2021 — ACE MDI Spacer with Small Mask - Product Usage: designed to assist with the delivery of aerosolized medications from metered dose inhaler canisters and with mechanically ventilated patients.

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