Embrace2- Indicated for use as an adjunct to seizure recall
Embrace2- Indicated for use as an adjunct to seizure monitoring of adults and children age 6 and up in home or healthcare facilities during periods of…
Why was Embrace2- Indicated for use as an adjunct to seizure recalled?
May have a battery life lasting less than the full 48 hours, requiring the device to be charged more frequently.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
UDI-DI: (1) Flamingo Pink EM2-FP-S - 00853858006133; (2) Sky Blue EM2-SB-2 - 00853858006140; (3) Seoul Grey EM2-SG-S - 00853858006126; (4) Boston Blue EM2-BB-S - 00853858006119; (5) Milan Black EM2-MB-S - 00853858006102 Lot Numbers: G11/H11
- Product
- Embrace2- Indicated for use as an adjunct to seizure monitoring of adults and children age 6 and up in home or healthcare facilities during periods of…
- Recalling firm
- EMPATICA SRL
- Quantity
- 1360 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Italy, Ireland, Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Germany, Finland, Netherlands, Poland, Sweden.
- Recall date
- November 1, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)