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U.S. Department of Health and Human Services

Class 3 Device Recall Olympus OFP Flushing Pump irrigation tubing

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  Class 3 Device Recall Olympus OFP Flushing Pump irrigation tubing see related information
Date Initiated by Firm December 12, 2011
Date Posted January 18, 2012
Recall Status1 Terminated 3 on September 25, 2012
Recall Number Z-0806-2012
Recall Event ID 60613
510(K)Number K000948  
Product Classification Pump, air, non-manual, for endoscope - Product Code FEQ
Product Olympus OFP Flushing Pump irrigation tubing

The Olympus OFP Flushing Pump is a peristaltic flushing pump intended for use with Olympus gastrointestinal videoscopes having an auxiliary water inlet as part of an Olympus endoscopic imaging system to facilitate washing of gastric and colonic mucosa to remove blood, feces and other organic matter, enabling improved visualization, diagnosis and therapy during endoscopic procedures.
Code Information Catalog number 7501669
Recalling Firm/
Olympus America Inc.
3500 Corporate Pkwy.
P.O. Box 610
Center Valley PA 18034-0610
For Additional Information Contact Laura Storms-Tyler
Manufacturer Reason
for Recall
Water may leak from the irrigation tubing used on the Olympus Flushing Pump
FDA Determined
Cause 2
Nonconforming Material/Component
Action The firm,Olympus, sent an "URGENT-DEVICE CORRECTION " letter dated December 12, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were informed that any current irrigation tubing in their inventory can be used with the OFP pump; however, they must inspect the tubing installed on the OFP pump for signs of water leakage; if leakage is found, discontinue use of the tubing and replace with a new irrigation tube. In addition, complete and return the enclosed questionnaire via fax to (484) 896-7128. If you do not wish to use your current inventory of irrigation tubing and would like a replacement, call Olympus Customer Care Center at 1-800-848-9024. Olympus is discontinuing the current version of irrigation tubing and has redesigned the irrigation tubing to prevent water leakage. For any additional information, contact the V.P., Regulatory/Clinical Affairs & Quality Assurance at (484) 896-5688 or email at laura.storms-tyler@olympus.com.
Quantity in Commerce 64,667 packages of 10 irrigation tubes
Distribution Nationwide distribution: USA including states of: AL, AK, AZ, AR, CA, CO, CT, DC, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, AND WY.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = FEQ and Original Applicant = KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD.