Reported Apr 4, 2018 · Terminated
Norm-Ject Tuberkulin Syringe, Catalog Number: K-ATS-1000, Global Product Number: G19871 Product Usage: Used to place in…
Cook Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cook Inc. · 750 N Daniels Way · Bloomington, IN · 47404-9120
Is this the product you have?
- Norm-Ject Tuberkulin Syringe
- Catalog NumberK-ATS-1000
- Global Product NumberG19871
- Product UsageUsed to place in vitro fertilized (IVF) embryos into the uterine cavity. Intended for one-time use
- Lot codes and dates
- Lot Numbers5667080 (Expiration
- Date11/30/2019)
- NS6127577 (Expiration Date4/30/2020)
- Amount recalled
- 1900
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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