Recall Z-1186-2018
Cook Inc. · initiated December 19, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Echosight Jansen-Anderson Intratubal Transfer Set, Catalog Number: K-J-JITS-572900, Global Product Number: G17946 Product Usage: Used to place in vitro fertilized (IVF) embryos into the uterine cavity. Intended for one-time use
Codes / lots: Lot Number: 7131328, Expiration Date: 7/19/2019
Reason for recall
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.
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-1186-2018
- Initiated
- December 19, 2017
- Terminated
- April 9, 2019
- Product code
- MQF – Catheter, Assisted Reproduction
- Quantity
- 57
- 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.
- Recalling firm
- Cook Inc., Bloomington, IN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1185-2018 Class II | Norm-Ject Tuberkulin Syringe, Catalog Number: K-ATS-1000, Global Product Number: G19871…Certain lots of in vitro fertilization (IVF) products were distributed without completed finished device… | 12/19/2017Terminated |
| Z-1187-2018 Class II | Marrs Laparoscopic GIFT Catheters, Catalog Number:K-J-MLC-503000, Global Product Number:…Certain lots of in vitro fertilization (IVF) products were distributed without completed finished device… | 12/19/2017Terminated |
| Z-1188-2018 Class II | 1. SMS Embryo Transfer Set, Catalog Number: K-J-SMS-571800, Global Product Number:…Certain lots of in vitro fertilization (IVF) products were distributed without completed finished device… | 12/19/2017Terminated |