Recall Z-3179-2011 ยท KQT Evacuator, Gastro-Urology
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
| Date | Sep 9, 2011 (initiated Jul 25, 2011) |
| Status | Terminated |
| 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) 6 |
| Quantity | 10,680 sets |
| Distribution | Nationwide distribution: USA including states of: CA, FL, ID, IL, MI, NY, PA, SD and WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K921451 | EVACUATOR, GASTRO-UROLOGY Northgate Technologies, Inc., Oct 28, 1992 |