Z-1185-2018Class II

Norm-Ject Tuberkulin Syringe, Catalog Number: K-ATS-1000, Global Product Number: G19871

Name: Z-1185-2018 Norm-Ject Tuberkulin Syringe, Catalog Number: K-ATS-1000, Global Product Number: G19871
Creator: Cook Inc.
Published: 2017-12-19
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2017-12-19 / Terminated / root cause: manufacturing process

FDA source

Cook Inc. began a recall of 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... on 2017-12-19. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1185-2018
Classification: Class II
Status: Terminated
Initiated: 2017-12-19
Posted: 2018-03-26
Terminated: 2019-04-09
Recalling firm: Cook Incorporated
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
Product code: KYZ Syringe, Irrigating (Non Dental)
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.
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 1900
Distribution: 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.
Product codes and lots: Lot Numbers: 5667080 (Expiration Date: 11/30/2019), NS6127577 (Expiration Date: 4/30/2020)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1185-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1185-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-26
Z-1186-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-26
Z-1187-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-26
Z-1188-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-26

Product code KYZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)