Reported May 5, 2021 · Terminated
ACE MDI Spacer with Small Mask - Product Usage: designed to assist with the delivery of aerosolized medications from…
Smiths Medical ASD Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Smiths Medical ASD Inc. · 6000 Nathan Ln N · Minneapolis, MN · 55442-1690
Is this the product you have?
- ACE MDI
- Spacer with Small Mask - Product Usagedesigned to assist with the delivery of aerosolized medications from metered dose inhaler canisters and with mechanically ventilated patients
- Lot codes and dates
- Device Model Number11-1122
- Lot Number3809856
- Amount recalled
- 250 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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