FDAFDA · Food and drugs·Recall number Z-0415-2020
Guardia Access Nano Embryo Transfer Catheter is use for transferring IVF embryos into the uterine cavity.
Published November 27, 2019 · Recall initiated: October 3, 2019
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
Bent transfer catheter tips may cause difficulty or inability in inserting the transfer catheter into the guiding catheter. Potential adverse events that may occur if an affected product is used include increased procedural time, the need for a repeat embryo transfer procedure, or the need for a patient to undergo an additional IVF cycle.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Cook Inc.
- Distributor
- No US distribution. The products were distributed to the following foreign countries: Belgium, Denmark, Germany, Italy, Netherlands, Norway, Poland, Republic of Macedonia, Slovenia, Spain, and Switzerland.
- Lot
- Lot Number 9502915
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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