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
Reported: April 4, 2018 Initiated: December 19, 2017 #Z-1188-2018
Product Description
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
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.
Details
- Recalling Firm
- Cook Inc.
- Units Affected
- 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.
- Location
- Bloomington, IN
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Cook Inc.. Units affected: 473.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 4, 2018. Severity: Moderate. Recall number: Z-1188-2018.
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