Cook recalls specific lots of IVF catheters due to potential nonviable gametes and embryos from incomplete quality testing. Affected units have catalog number K-J-MLC-503000 and global product number G18022.
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 laparoscopic GIFT catheters used in IVF procedures because they were distributed without completed quality testing. This could lead to nonviable gametes or embryos, which may affect fertility outcomes.
The catheters were distributed without completed quality testing, which could result in nonviable gametes or embryos. This means the IVF process might not produce viable embryos, potentially affecting fertility outcomes.
Individuals who used or own the specific lot numbers of Cook's Marrs Laparoscopic GIFT Catheters (Catalog Number: K-J-MLC-503000) for IVF procedures. Patients undergoing fertility treatments are most at risk.
Check for the catalog number K-J-MLC-503000 and global product number G18022 on the catheter packaging. The lot number 5571684 and expiration date 1/12/2018 are also associated with this recall.
Look for the catalog number K-J-MLC-503000 and global product number G18022 on the catheter packaging.
The catheters were distributed without completed finished device quality testing, which could lead to nonviable gametes or embryos.
Check the catalog number and global product number on the packaging to see if it's affected. If it is, contact Cook for further instructions.
The recall states potential nonviable gametes and embryos, but there is no mention of physical injury risks. This is considered a low-risk issue.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-1187-2018 — Cook Cook Hello, I own a Cook that is covered by recall Z-1187-2018 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.
