Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1185-2018 — 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

U.S. FDA — Device Enforcement · United States · 2017-12-19 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1185-2018
Date of alert
2017-12-19
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Cook Inc.
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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