SURESOUND22US Multipack recall: Sterility Concern
SURESOUND22US Multipack (US Distribution) containing 2 packs of six devices. SURESOUND22 Multipack (OUS Distribution) containing 2 packs of six…
Why was SURESOUND22US Multipack recalled?
Breach in sterile barrier compromising product sterility
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?
Lot Code US: 16E25RC 16E25RD 16F16R Lot Code OUS: 16E25RB
- Product
- SURESOUND22US Multipack (US Distribution) containing 2 packs of six devices. SURESOUND22 Multipack (OUS Distribution) containing 2 packs of six…
- Recalling firm
- Hologic, Inc
- Quantity
- 600 units (US) ; 24 units (OUS)
- Distribution
- Worldwide Distribution - US (Nationwide) and Internationally to Finland and Austria.
- Recall date
- November 30, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)