FDAFDA · Food and drugs·Recall number Z-0053-2018
Alcon Custom Pak
Published November 8, 2017 · Recall initiated: August 8, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Alcon is initiating a medical device recall, after receiving notification from a supplier of a recall for x-ray detectable sponges. The one product referenced in the supplier recall notification, is used within Alcon Custom Paks.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Alcon Research, LTD.
- Distributor
- States in the US - WI, NY, MO
- Lot
- 2033459H, 2034186H, 2034491H
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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