Recall Z-1188-2018 ยท MQF Catheter, Assisted Reproduction
Cook Inc.
1. SMS Embryo Transfer Set, Catalog Number: K-J-SMS-571800, Global Product Number: G19182; 2. Guardia" Access Nano Embryo Transfer Catheter, Catalog Number: K-JETS-551910-L, Global Product Number: G24215; 3. Sydney IVF Embryo Transfer Set, Product Number: K-JETS-7019-SIVF, Global Product Number: G18740
| Date | Dec 19, 2017 |
| Status | Terminated |
| Reason | Certain lots of in vitro fertilization (IVF) products were distributed without completed finished device quality testing with potential adverse events that may include nonviable gametes and/or nonviable embryos. |
| Root cause | Process control |
| Action | Cook Medical sent an Urgent Medical Device Recall dated December 19, 2017 to customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to: 1. Examine inventory immediately and quarantine affected product(s). 2. Return products to Cook with the Acknowledgement and Receipt Form to receive a product credit. 3. Complete and return the Acknowledgement and Receipt Form within 5 business days of receiving this letter. 4.Report adverse events to Cook. For questions contact Cook Medical Customer Relations at 800-457-4500 or 812-339-2235. |
| Quantity | 473 |
| Distribution | Worldwide Distribution - U.S. Nationwide in the states of: CA, CO, FL, IN, MA, NE, NJ, OH, TN, TX, and WI. and countries of Belarus, Belgium, Brazil, Canada, Chile, China, Egypt, Italy, Japan, Poland, Saudi Arabia, Spain, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K983594 | EMBRYO TRANSFER CATHETERS/SETS Cook Ob/Gyn, Dec 21, 1998 |