medical Class II Updated 2019-11-27

Cook Inc. recalls Guardia Access Embryo Transfer Catheter is used for transfer

Recalled Product

Guardia Access Embryo Transfer Catheter is used for transferring IVF embryos into the uterine cavity.


Hazard / Issue

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.

Issued by

FDA

Distribution: 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/Code Info: Lot Number 8361746
View official government recall

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