The Recall Desk
HighFDA (Devices)·Z-1187-2018·Announced 2018-04-04

Cook Inc. Recalls Marrs Laparoscopic GIFT Catheters Due to Quality Testing Gaps

Cook Inc. is recalling 21 Marrs Laparoscopic GIFT Catheters because they were distributed without completed quality testing, posing a risk of nonviable embryos.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a risk of harm (nonviable embryos) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.

Plain-English summary

Cook Inc. is recalling 21 units of Marrs Laparoscopic GIFT Catheters (Catalog Number K-J-MLC-503000, Global Product Number G18022). These medical devices are intended for one-time use to place in vitro fertilized (IVF) embryos into the uterine cavity. The specific lot number is 5571684, with an expiration date of 1/12/2018.

The recall was initiated because the devices were distributed without completed finished device quality testing. This lack of testing creates a potential for adverse events, specifically the use of nonviable gametes and/or nonviable embryos during IVF procedures.

The affected products were distributed worldwide, including in the United States (CA, CO, FL, IN, MA, NE, NJ, OH, TN, TX, and WI) and in Belarus, Belgium, Brazil, Canada, Chile, China, Egypt, Italy, Japan, Poland, Saudi Arabia, Spain, and the United Kingdom. Healthcare providers and patients should stop using the affected devices and contact Cook Inc. for further instructions.

The recalled product

Product
Marrs Laparoscopic GIFT Catheters, Catalog Number:K-J-MLC-503000, Global Product Number: G18022 Product Usage: Used to place in vitro fertilized (IVF) embryos into the uterine cavity. Intended for one-time use
Manufacturer
Cook Inc.
Category
Medical Device — Reproductive Health
Hazard
Affected units
21

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot Number: 5571684
  • Expiration Date: 1/12/2018

Distribution

Distributed nationwide across the United States.

The notice also names 11 states specifically:

Part of a larger recall action

This product is one of 4 recalled by Cook Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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