The Recall Desk

FDA (Devices) recall action 79471

Cook Inc. recalled 4 products on 2018-04-04

The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.

Products
4
Announced
2018-04-04
Critical
0
Units
2,451

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–4 of 4

  • HighFDA (Devices)··2018-04-04

    Cook Inc. Recalls Marrs Laparoscopic GIFT Catheters Due to Quality Testing Gaps

    Cook Inc. is recalling 21 Marrs Laparoscopic GIFT Catheters because they were distributed without completed quality testing, posing a risk of nonviable embryos.

    Product
    Marrs Laparoscopic GIFT Catheters, Catalog Number:K-J-MLC-503000, Global Product Number: G18022 Product Usage: Used to place in vitro fertilized (IVF) embryos into the uterine cavity. Intended for one-time use
    Category
    Distribution
    11 states
  • HighFDA (Devices)··2018-04-04

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

    Cook Inc. is recalling specific lots of IVF embryo transfer sets and catheters because they were distributed without completed quality testing, posing a risk of nonviable gametes or embryos.

    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, Globa
    Category
    Distribution
    11 states
  • HighFDA (Devices)··2018-04-04

    Cook Inc. Recalls IVF Embryo Transfer Syringes Due to Quality Testing Gaps

    Cook Inc. is recalling specific lots of Norm-Ject Tuberkulin Syringes used for IVF embryo transfer because they were distributed without completed quality testing.

    Product
    Norm-Ject Tuberkulin Syringe, Catalog Number: K-ATS-1000, Global Product Number: G19871 Product Usage: Used to place in vitro fertilized (IVF) embryos into the uterine cavity. Intended for one-time use
    Category
    Distribution
    11 states
  • HighFDA (Devices)··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.

    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
    Category
    Distribution
    11 states