Recall Z-0415-2020— Cook Inc.
Class II · Terminated
Class II FDA medical device recall by Cook Inc., initiated 2019-10-03, terminated 2020-05-13. It names one FDA 510(k) clearance: K983594. Product: Guardia Access Nano Embryo Transfer Catheter is use for transferring IVF embryos into the uterine cavity.. Reason: 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..
- Recalling firm
- Cook Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-10-03
- Terminated
- 2020-05-13
- Firm location
- Bloomington, IN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.