Z-0415-2020 Class II Terminated
FDA device recall Z-0415-2020 was initiated by Cook Inc. on October 3, 2019 and is designated Class II. 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 incl… The recall status is terminated (terminated May 13, 2020). Affected quantity: 202.
Recall Details
- Product Type
- Devices
- Report Date
- November 27, 2019
- Initiation Date
- October 3, 2019
- Termination Date
- May 13, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 202
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.
Distribution Pattern
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.
Code Information
Lot Number 9502915