Device product
Marrs Laparoscopic GIFT Catheters, Catalog Number:K-J-MLC-503000, Global Product Number: G18022 Product Usage: Used to place in vitro fertilized (IVF) embryos into the uterine cavity. Intended for one-time use
Z-1187-2018
Product summary
- Firm
- Cook Inc.
- Event
- Event 79471
- Status
- Terminated
- Classification
- Class II
- Quantity
- 21
- Official record key
device-enforcement:Z-1187-2018
Official wording
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.
Code information: Lot Number: 5571684, Expiration Date: 1/12/2018
Distribution pattern: 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.
Derived failure modes
-
Unknown
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.