—#162422

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

FDA product code: KYZ — Syringe, Irrigating (Non Dental)
Device class: Class 1
Medical specialty: General Hospital
Affected lot / code info: Lot Numbers: 5667080 (Expiration Date: 11/30/2019), NS6127577 (Expiration Date: 4/30/2020)

Why it was recalled

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.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Cook Inc.
Address: 750 N Daniels Way, Bloomington, Indiana 47404-9120

Distribution

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.

Timeline

Recall initiated: 2017-12-19
Terminated: 2019-04-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #162422. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.