Recall Z-2213-2010
Minntech Corp · initiated June 15, 2010
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.
Codes / lots: 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.
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 taken
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.
Details
- Recall number
- Z-2213-2010
- Initiated
- June 15, 2010
- Posted by FDA
- August 12, 2010
- Terminated
- December 17, 2011
- Product code
- FEB – Accessories, Cleaning, For Endoscope
- Quantity
- 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.
- Recalling firm
- Minntech Corp, Plymouth, MN