Recall Z-0415-2020
Cook Inc. · initiated October 3, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Guardia Access Nano Embryo Transfer Catheter is use for transferring IVF embryos into the uterine cavity.
Codes / lots: Lot Number 9502915
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.
FDA-determined cause: Under Investigation by firm
Action taken
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 the returned affected products where applicable.
Details
- Recall number
- Z-0415-2020
- Initiated
- October 3, 2019
- Terminated
- May 13, 2020
- Product code
- MQF – Catheter, Assisted Reproduction
- 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.
- Recalling firm
- Cook Inc., Bloomington, IN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0416-2020 Class II | Guardia Access Embryo Transfer Catheter is used for transferring IVF embryos into the…Bent transfer catheter tips may cause difficulty or inability in inserting the transfer catheter into the… | 10/03/2019Terminated |