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U.S. Department of Health and Human Services

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

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 Class 2 Recall
DSD Application Guide (MG040001 revision M) for Pentax Universal Video Scope Hookup:DSD110HU0109
see related information
Date Posted August 12, 2010
Recall Status1 Terminated on December 17, 2011
Recall Number Z-2213-2010
Recall Event ID 56189
Premarket Notification
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, Minnesota 55447-4822
Consumer Instructions Contact the recalling firm for information
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 2
MISBRANDING: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FEB and Original Applicant = MEDIVATORS, INC.
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