ACE MDI Spacer with Small Mask - Product Usage recall
ACE MDI Spacer with Small Mask - Product Usage: designed to assist with the delivery of aerosolized medications from metered dose inhaler canisters…
Why was ACE MDI Spacer with Small Mask - Product Usage 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Device Model Number: 11-1122; Lot Number: 3809856
- Product
- ACE MDI Spacer with Small Mask - Product Usage: designed to assist with the delivery of aerosolized medications from metered dose inhaler canisters…
- Recalling firm
- Smiths Medical ASD Inc.
- Quantity
- 250 units
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of PA and MN. The countries of Columbia, Germany, Greece, Hong Kong, Qatar, Thailand, and United Arab Emirates.
- Recall date
- May 5, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)