FDA Medical Device Recalls (openFDA)
Northgate Technologies, Inc.: 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.
- Recall number
- Z-3179-2011
- 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.
- Status
- Terminated
- Initiated
- 2011-07-25
- Posted
- 2011-09-09
- Terminated
- 2011-12-14
- Reason
- 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
- 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: ckurek@northgate-tech.com.
- Quantity
- 10,680 sets
- Distribution
- Nationwide distribution: USA including states of: CA, FL, ID, IL, MI, NY, PA, SD and WV.
- Lot, serial or model codes
- catalog #72-00114-0, lot numbers NW8616, NW8773, NW9044, NW9219, NW9352, NW9527 and NW9700
- 510(k) numbers
- ["K921451"]
- PMA numbers
- not on file
- Product code
- KQT
- Firm FEI
- 1450997
- Firm city
- Elgin
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28