RecallRadar

FDA Device recall Z-1186-2018

Echosight Jansen-Anderson Intratubal Transfer Set, Catalog Number: K-J-JITS-572900, Global Product Number: G17946 Product Usage: Used to pl…

On 2018-04-04 the FDA classified a Class II recall of Echosight Jansen-Anderson Intratubal Transfer Set, Catalog Number: K-J-JITS-572900, Global Product Number: G17946 Product Usage: Used to pl… by Cook, citing certain lots of in vitro fertilization (IVF) products were distributed without completed finished device quality testing with potential adverse events that may include nonviable g….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1186-2018
ClassificationClass II
Statusterminated
Initiated2017-12-19
Published2018-04-04
Last updated2026-09-13 11:54 UTC
CompanyCook
DistributionUS

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

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.

Identifiers

code_infoLot Number: 7131328, Expiration Date: 7/19/2019

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1186-2018%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.