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U.S. Department of Health and Human Services

Class 2 Device Recall Olympus Fluid Aspiration Set

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 Class 2 Device Recall Olympus Fluid Aspiration Setsee related information
Date Initiated by FirmJuly 25, 2011
Date PostedSeptember 09, 2011
Recall Status1 Terminated 3 on December 14, 2011
Recall NumberZ-3179-2011
Recall Event ID 59656
510(K)NumberK921451 
Product Classification Evacuator, gastro-urology - Product Code KQT
ProductOlympus 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.
Code Information catalog #72-00114-0, lot numbers NW8616, NW8773, NW9044, NW9219, NW9352, NW9527 and NW9700
FEI Number 1450997
Recalling Firm/
Manufacturer		 Northgate Technologies, Inc.
1591 Scottsdale Court
Elgin IL 60123-9340
For Additional Information Contact
224-856-2222
Manufacturer 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.
FDA Determined
Cause 2		Employee error
ActionThe 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 in Commerce10,680 sets
DistributionNationwide distribution: USA including states of: CA, FL, ID, IL, MI, NY, PA, SD and WV.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = KQT
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