Recall Z-1188-2018— Cook Inc.

Name: FDA recall Z-1188-2018
Creator: U.S. Food and Drug Administration
Published: 2017-12-19

Class II · Terminated

Class II FDA medical device recall by Cook Inc., initiated 2017-12-19, terminated 2019-04-09. It names one FDA 510(k) clearance: K983594. 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: 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..

Recalling firm: Cook Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-12-19
Terminated: 2019-04-09
Firm location: Bloomington, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K983594 — EMBRYO TRANSFER CATHETERS/SETSCook Ob/Gyn·cleared 1998-12-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.