Z-1698-2011

The Waste Line Assembly and the Waste Outlet Tubing and the Waste Bottle Cable are components that are used...

Name: Z-1698-2011 The Waste Line Assembly and the Waste Outlet Tubing and the Waste Bottle Cable are components that are used...
Creator: Abbott Laboratories
Published: 2009-11-30
License: https://open.fda.gov/license/

Abbott Medical / initiated 2009-11-30 / Terminated

FDA source

Abbott Laboratories began a recall of The Waste Line Assembly and the Waste Outlet Tubing and the Waste Bottle Cable are components that are used on one or more CELL-DYN Systems. Usage: Accessories... on 2009-11-30. The reason FDA records is "The use of the device assemblies has been extended to a 6 month useful life". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1698-2011
Status: Terminated
Initiated: 2009-11-30
Posted: 2011-03-17
Terminated: 2011-03-18
Recalling firm: Abbott Medical
Product: The Waste Line Assembly and the Waste Outlet Tubing and the Waste Bottle Cable are components that are used on one or more CELL-DYN Systems. Usage: Accessories to human waste container systems
Product code: GKZ Counter, Differential Cell
Reason for recall: The use of the device assemblies has been extended to a 6 month useful life.
FDA root cause: Other
Action: The firm, Abbott Laboratories, sent a "Product Correction" letter dated November 30, 2009 to all consignees/customers. The letter described the product, problem and actions to be taken. The letter stated that Abbott recommended that the customers change their Waste Line Assembly and Waste Outlet Tubing every six months and included a tag in the letter to record installation and replacement dates. Additionally, the customers were instructed to keep this communication with their CELL-DYN System Operator's Manual and complete and return the Customer Reply form via fax to 1-800-777-0051 or email [email protected] even if they no longer have the instrument. If you have any questions regarding this communication, U.S. customers should call Customer Support at 1-877-4ABBOTT (1-877-422-2688). Customers outside the U.S. please contact your local hematology customer support representative.
Quantity in commerce: 874
Distribution: Worldwide distribution: AL, AR, AZ, CA. CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO MS, MT , NC, NE, NJ, NM, NY, OH, OK, PA, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY; and countries including: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, Costa Rica, Dominican Republic, Germany, Guatemala, Hong Kong, Japan, Mexico, New Zealand, Panama, Peru, Puerto Rico, Singapore, South Korea, Thailand, Trinidad and Tobago, and Uruguay.
Product codes and lots: Model Numbers: 92161-02 and 06H54-01 for the Waste Line Assembly; 02H96-01 for the Waste Outlet Tubing; and 03H98-02 for the Waste Bottle Cable.

Product code GKZ

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)