Z-3179-2011

Olympus Fluid Aspiration Set; a sterile set of silicone tubing and connectors for use with the Olympus SP-2...

Name: Z-3179-2011 Olympus Fluid Aspiration Set; a sterile set of silicone tubing and connectors for use with the Olympus SP-2...
Creator: Northgate Technologies, Inc.
Published: 2011-07-25
License: https://open.fda.gov/license/

Northgate Technologies Inc. / initiated 2011-07-25 / Terminated / root cause: manufacturing process

FDA source

Northgate Technologies, Inc. began a recall of Olympus Fluid Aspiration Set; a sterile set of silicone tubing and connectors for use with the Olympus SP-2 Fluid Irrigation & Aspiration Pump; 10 sets per... on 2011-07-25. The reason FDA records is "The Red Tag was assembled to the wrong end of the silicone tubing. The Red Tag indicates how the fluid aspiration tubing set is loaded into the Olympus SP-2 Fluid Irrigation and Aspiration Pump". 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-3179-2011
Status: Terminated
Initiated: 2011-07-25
Posted: 2011-09-09
Terminated: 2011-12-14
Recalling firm: Northgate Technologies Inc.
Product: Olympus Fluid Aspiration Set; a sterile set of silicone tubing and connectors for use with the Olympus SP-2 Fluid Irrigation & Aspiration Pump; 10 sets per box; Manufactured for: Olympus America Inc., Two Corporate Center Drive, Melville, NY 11747-3157; catalog #72-00114-0 The fluid aspiration set is used in conjunction with the Olympus SP-2 pump for fluid aspiration during urological endoscopic procedures or laparoscopic procedures.
Product code: KQT Evacuator, Gastro-Urology
Reason for recall: The Red Tag was assembled to the wrong end of the silicone tubing. The Red Tag indicates how the fluid aspiration tubing set is loaded into the Olympus SP-2 Fluid Irrigation and Aspiration Pump.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: The firm, Northgate Technologies, sent an "URGENT: MEDICAL DEVICE RECALL" letters dated August 18, 2011 to the Olympus America customers who ordered the Aspiration Tubing Set, 72-00114-0. The letter describes the product, problem and actions to be taken. The customers were instructed to immediately examine their inventory and quarantine the product subject to recall for subsequent return to Northgate Technologies; if they further distributed this product, they were to identify and notify their customers of the recall, and complete and return the enclosed Return Response Form via fax to (847) 608-9405 or mail to: Northgate Technologies Inc., 1591 Scottsdale Court, Elgin, IL 60123. If you have any questions, please call (224) 856-2222 or e-mail to: [email protected].
Quantity in commerce: 10,680 sets
Distribution: Nationwide distribution: USA including states of: CA, FL, ID, IL, MI, NY, PA, SD and WV.
Product codes and lots: catalog #72-00114-0, lot numbers NW8616, NW8773, NW9044, NW9219, NW9352, NW9527 and NW9700

Product code KQT

K921451Class IIEvacuator, Gastro-UrologyNorthgate Technologies, Inc. / cleared 1992-10-28

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)