FDA-Device2019-11-27Class II
Guardia Access Nano Embryo Transfer Catheter is use for transferring IVF embryos into the uterine cavity.
Cook Inc.
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.
Sold states
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.
Affected count
202
Manufactured in
750 N Daniels Way, N/A, Bloomington, IN, United States
Products
Guardia Access Nano Embryo Transfer Catheter is use for transferring IVF embryos into the uterine cavity.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0415-2020Don't want to check this manually?
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