Cook recalls Norm-Ject Tuberkulin Syringes (Catalog K-ATS-1000) used in IVF procedures due to potential nonviable gametes or embryos from incomplete quality testing.
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.
Cook is recalling certain lots of Norm-Ject Tuberkulin Syringes used in IVF procedures because they may have been distributed without completed quality testing, potentially causing nonviable gametes or embryos.
The syringes were distributed without completed finished device quality testing. This could lead to nonviable gametes or embryos being used in IVF procedures, though the exact mechanism is not specified.
Individuals using these syringes for in vitro fertilization procedures. Those with IVF embryos at risk if the syringes were used without proper quality testing.
Check for Catalog Number K-ATS-1000 and Global Product Number G19871. The affected lots are 5667080 (expires 11/30/2019) and NS6127577 (expires 4/30/2020).
Look for lot numbers 5667080 or NS6127577 on the syringe packaging.
The syringes were distributed without completed finished device quality testing, which could result in nonviable gametes or embryos during IVF procedures.
Check the lot number on the syringe packaging. If it matches 5667080 or NS6127577, contact Cook for guidance.
The recall is due to potential nonviable gametes or embryos, but the exact risk level is not specified in the notice.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-1185-2018 — Cook Cook Hello, I own a Cook that is covered by recall Z-1185-2018 from Cook. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
