# FDA recall Z-1188-2018

> **Cook Inc.** · Class II · device recall initiated 2017-12-19.

## Product

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.

## 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.

## Key facts

- **Recall number:** Z-1188-2018
- **Recalling firm:** Cook Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-12-19
- **Report date:** 2018-04-04
- **Termination date:** 2019-04-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bloomington, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1188-2018

## Citation

> AI Analytics. FDA recall Z-1188-2018. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1188-2018. Source: US FDA. Licensed CC0.

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