Cook Inc. recalls Guardia Access Nano Embryo Transfer Catheter is use for transferring IVF embryos into the uterine cavity.

Recall date

October 3, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0415-2020

FDA classification

Class II

Brand / firm

Cook Inc.

Sold / distributed

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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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