Olympus Fluid Aspiration Set; a sterile set of silicone tubing and connectors for use with the Olympus SP-2 Fluid Irriga
FDA device recall Z-3179-2011 · posted 2011-09-09 · Terminated
Recall details
- Recalling firm
- Northgate Technologies, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- KQT
- Quantity affected
- 10,680 sets
- Distribution
- Nationwide distribution: USA including states of: CA, FL, ID, IL, MI, NY, PA, SD and WV.
- Date initiated
- 2011-07-25
- Date posted
- 2011-09-09
- Date terminated
- 2011-12-14
- Location
- Elgin, IL
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EVACUATOR, GASTRO-UROLOGY (K921451) | Northgate Technologies, Inc. | 1992-10-28 |