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Cook Inc. Recall: Norm-Ject Tuberkulin Syringe, Catalog Number: K-ATS-1000, Global Produ

Cook Inc. Recall: Norm-Ject Tuberkulin Syringe, Catalog Number: K-ATS-1000, Global Produ is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Cook Inc.; Product: Norm-Ject Tuberkulin Syringe, Catalog Number: K-ATS-1000, Global Product Number: G19871 Product Usage: Used to place in vitro fer

Recalling firmCook Inc.
ProductNorm-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
Reason for recallCertain 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.
ClassificationClass II (moderate — may cause temporary or reversible health consequences)
StatusTerminated
DistributionWorldwide Distribution - U.S. Nationwide in the states of: CA, CO, FL, IN, MA, NE, NJ, OH, TN, TX, and WI. and countries of Belarus, Belgium, Brazil, Canada, Chile, China, Egypt, Italy, Japan, Poland, Saudi Arabia, Spain, and United Kingdom.
Recall initiated20171219
Recall numberZ-1185-2018
Categorydevice
StateIN
CountryUnited States

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