The Recall Desk
HighFDA (Devices)·Z-1186-2018·Announced 2018-04-04

Cook Inc. Recalls IVF Intratubal Transfer Sets Due to Quality Testing Gaps

Cook Inc. is recalling specific lots of Echosight Jansen-Anderson Intratubal Transfer Sets because they were distributed without completed quality testing, posing a risk of nonviable embryos.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device where quality testing was not completed, creating a risk of harm (nonviable embryos) without reported injuries or illnesses, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Cook Inc. is recalling 57 units of the Echosight Jansen-Anderson Intratubal Transfer Set (Catalog Number: K-J-JITS-572900, Global Product Number: G17946). The affected product is identified by Lot Number 7131328 and has an expiration date of 7/19/2019. This medical device is intended for one-time use to place in vitro fertilized (IVF) embryos into the uterine cavity.

The recall was initiated because certain lots of these IVF products were distributed without completed finished device quality testing. The source text indicates that this lack of testing creates a potential for adverse events, specifically the presence of nonviable gametes and/or nonviable embryos.

The affected units were distributed worldwide, including nationwide in the United States in the states of CA, CO, FL, IN, MA, NE, NJ, OH, TN, TX, and WI. International distribution included Belarus, Belgium, Brazil, Canada, Chile, China, Egypt, Italy, Japan, Poland, Saudi Arabia, Spain, and the United Kingdom. Users should check their inventory for the specific lot number and expiration date listed above.

The recalled product

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
Manufacturer
Cook Inc.
Category
Medical Device — Reproductive Health
Hazard
Affected units
57

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot Number: 7131328
  • Expiration Date: 7/19/2019

Distribution

Distributed nationwide across the United States.

The notice also names 11 states specifically:

Part of a larger recall action

This product is one of 4 recalled by Cook Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Related recalls

Same manufacturer · Cook Inc.

See all →

Same hazard · quality testing

See all →