The Recall Desk
HighFDA (Devices)·Z-1185-2018·Announced 2018-04-04

Cook Inc. Recalls IVF Embryo Transfer Syringes Due to Quality Testing Gaps

Cook Inc. is recalling specific lots of Norm-Ject Tuberkulin Syringes used for IVF embryo transfer because they were distributed without completed quality testing.

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 involves a medical device with a risk of harm (nonviable embryos) where the agency has not reported specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Cook Inc. is recalling 1,900 units of Norm-Ject Tuberkulin Syringes (Catalog Number: K-ATS-1000, Global Product Number: G19871). These syringes are intended for one-time use to place in vitro fertilized (IVF) embryos into the uterine cavity. The recall affects specific lots with expiration dates of 11/30/2019 and 4/30/2020.

The recall was initiated because the affected syringes were distributed without completed finished device quality testing. The FDA notes that this lack of testing creates a potential for adverse events, which may include nonviable gametes and/or nonviable embryos.

The products were distributed worldwide, including in the United States (CA, CO, FL, IN, MA, NE, NJ, OH, TN, TX, and WI) and in countries such as 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 lots and contact Cook Inc. for further instructions.

The recalled product

Product
Norm-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
Manufacturer
Cook Inc.
Category
Medical Device — Reproductive Health
Hazard
Affected units
1,900

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 Numbers: 5667080 (Expiration Date: 11/30/2019)
  • NS6127577 (Expiration Date: 4/30/2020)

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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