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Terminated

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

FDA Recall Z-1185-2018 · Posted None

Recalling FirmCook Inc.
Recall StatusTerminated
Product CodeKYZ
Date Initiated2017-12-19
Date Terminated2019-04-09
Product Quantity1900

Reason for Recall

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.

Firm Action

Cook Medical sent an Urgent Medical Device Recall dated December 19, 2017 to customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to: 1. Examine inventory immediately and quarantine affected product(s). 2. Return products to Cook with the Acknowledgement and Receipt Form to receive a product credit. 3. Complete and return the Acknowledgement and Receipt Form within 5 business days of receiving this letter. 4.Report adverse events to Cook. For questions contact Cook Medical Customer Relations at 800-457-4500 or 812-339-2235.

Root Cause

Process control

Distribution Pattern

Worldwide Distribution - U.S. Nationwide in the states of: CA, CO, FL, IN, MA, NE, NJ, OH, TN, TX, and WI. and countries of Belarus, Belgium, Brazil, Canada, Chile, China, Egypt, Italy, Japan, Poland, Saudi Arabia, Spain, and United Kingdom.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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