FDAFDA · Food and drugs·Recall number Z-3031-2018
Edwards Lifesciences Avid Dual Stage Venous Drainage Cannula, 29/37F (9.6/12.3MM) X 37CM (14.5"), resterilized.
Published September 19, 2018 · Recall initiated: March 7, 2018
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
The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- SPS Sterilization, Inc
- Distributor
- US distribution to AZ, CA, FL, OH, PA, TX, VA, WV
- Lot
- Code Number TF293702-R; Lot Number 59655659; Serial Numbers 18304192017-02, 18304192017-03, 18304192017-04, 18304192017-05, 18304192017-06
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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