Class 2 Device Recall DSD Application Guide (MG040001 revision M) for Pentax Universal Video Scope Hookup:DSD110HU0109

• Date Initiated by Firm: June 15, 2010
• Date Posted: August 12, 2010
• Recall Status: Terminated on December 17, 2011
• Recall Number: Z-2213-2010
• Recall Event ID: 56189
• 510(K)Number: K914145
• Product Classification: Accessories, cleaning, for endoscope - Product Code FEB
• Product: DSD Application Guide (MG04-0001 revision M) for the Pentax Universal Video Scope Hookup (DSD-110-HU0109) only when used with the DSD automated endoscope reprocessor (AER) and the Pentax EG-3630U endoscope.
• Code Information: A lot number listing is not applicable as this is a field correction of the labeling. The 0109 hookup itself is not defective and can still be used safely with other enodscopes.
• Recalling Firm/ Manufacturer: Minntech Corp; 14605 28th Ave N; Plymouth MN 55447-4822
• For Additional Information Contact: 763-553-3300
• Manufacturer Reason for Recall: The DSD hook up Application Guide incorrectly recommends use of the Medivators DSD-110-HU0109 endoscope hookup to connect the Pentax EG-3630U Ultrasound Endoscope to a Medivators DSD endoscope reprocessor or Medivators Scope Buddy Endoscope Flushing Aid. This may result in inadequate disinfection during reprocessing, and subsequent infection risk to the patient. The recall was due to the misprinte
• FDA Determined Cause: Labeling False and Misleading
• Action: Consignees were sent a Medivators Reprocessing Systems "Urgent Medical Device Recall" letter date June 17, 2010. The letter was addressed to "Dear Medivators Customers". The letter described the problem and product involved. Recommended consignees to immediately examine the Pentax EG-3630U Ultrasound Endoscope hookups and inform all staff of the notice to ensure that the DSD-11--HU01109 is not used with the Pentax endoscope. Also requested consignees to complete and return the enclosed response form.
• Quantity in Commerce: 185
• Distribution: AZ, AR, CA, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, MD, MA, MI, MN, MS, MO, NH, NJ, NY, NC, ND, OH, PA, SC, TN, TX, UT, VA, WA, WV, WI, 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 = FEB