Guardia Access Nano Embryo Transfer Catheter is use for transferring IVF embryos into the uterine cavity.
Reported: November 27, 2019 Initiated: October 3, 2019 #Z-0415-2020
Product Description
Guardia Access Nano Embryo Transfer Catheter is use for transferring IVF embryos into the uterine cavity.
Reason for Recall
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.
Details
- Recalling Firm
- Cook Inc.
- Units Affected
- 202
- 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.
- Location
- Bloomington, IN
Frequently Asked Questions
What product was recalled? ▼
Guardia Access Nano Embryo Transfer Catheter is use for transferring IVF embryos into the uterine cavity.. Recalled by Cook Inc.. Units affected: 202.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 27, 2019. Severity: Moderate. Recall number: Z-0415-2020.
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