Recall Z-0415-2020 ยท MQF Catheter, Assisted Reproduction
Cook Inc.
Guardia Access Nano Embryo Transfer Catheter is use for transferring IVF embryos into the uterine cavity.
| Date | Oct 3, 2019 |
| Status | Terminated |
| 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. |
| Root cause | Under Investigation by firm |
| Action | An Urgent Field Safety Notice letter dated 10/3/19 was sent to customers. The letter instructs customers to identify affected devices, quarantine the devices, return them, and complete the enclosed Customer Response Form. Where product is indicated as being returned, our Customer Services department will contact you to organize the return and issue you with the relevant Returns Authorization number. Please include contact details on the Customer Response form. Returned Product should be addressed to: Cook Medical EUDC Robert-Koch-Strae, 2 52499 Baesweiler GERMANY Credit will be provided for t |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K983594 | EMBRYO TRANSFER CATHETERS/SETS Cook Ob/Gyn, Dec 21, 1998 |