Smiths Medical recalls ACE MDI Spacers with Small Masks due to potential incorrect shipping box labels. This may affect product identification but does not pose a safety 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.
Smiths Medical is recalling ACE MDI Spacers with Small Masks because some units may have incorrect shipping box labels. This issue does not pose a safety risk but could lead to confusion about product identification.
The recall is due to potential incorrect shipping box labels on some units. This could cause confusion about which units are being used but does not affect the device's safety or function.
Healthcare professionals using ACE MDI Spacers with Small Masks for medical patients are likely affected. Patients using these devices are at minimal risk as the issue does not impact safety.
Check for the model number 11-1122 and lot number 3809856 on the shipping box. The product is designed for use with metered dose inhalers and ventilated patients.
Verify the model number 11-1122 and lot number 3809856 on the shipping box to confirm the product.
No, the recall is only for potential incorrect shipping labels and does not pose a safety risk.
Check the shipping box for model number 11-1122 and lot number 3809856 to confirm the product. No action is needed if labels are correct.
Look for the model number 11-1122 and lot number 3809856 on the shipping box. If these match, the product is not affected.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1516-2021 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-1516-2021 from Smiths Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
