Cook Inc. recalls three IVF embryo transfer sets with unverified quality testing that may cause nonviable gametes or embryos. Affected products include SMS Embryo Transfer Set (K-J-SMS-571800) and Guardia Access Nano.
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 Inc. is recalling three IVF embryo transfer sets that were distributed without completed quality testing. This could result in nonviable gametes or embryos. The recall affects specific lots of these products sold globally.
The products were distributed without completed finished device quality testing. This could lead to nonviable gametes or embryos, potentially affecting fertility outcomes.
Individuals using these IVF embryo transfer sets for in vitro fertilization may be affected. Those who have the specific lot numbers listed in the recall are most at risk.
Check the catalog number and global product number on the packaging. The affected products include SMS Embryo Transfer Set (K-J-SMS-571800), Guardia Access Nano (K-JETS-551910-L), and Sydney IVF Embryo Transfer Set (K-JETS-7019-SIVF).
Identify the catalog number and global product number on the packaging to confirm if your product is affected.
The products were distributed without completed finished device quality testing, which could result in nonviable gametes or embryos.
The affected products include SMS Embryo Transfer Set (Catalog Number: K-J-SMS-571800), Guardia Access Nano (Catalog Number: K-JETS-551910-L), and Sydney IVF Embryo Transfer Set (Catalog Number: K-JETS-7019-SIVF).
Check the catalog number and global product number on the packaging. The affected products have specific lot numbers listed in the recall notice.
We’ve drafted a message you can send Cook Inc. to request your refund or repair — edit it as you like.
Subject: Recall Z-1188-2018 — Cook Inc. Cook Inc. Hello, I own a Cook Inc. that is covered by recall Z-1188-2018 from Cook Inc.. 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.
