Z-2213-2010

DSD Application Guide (MG04-0001 revision M) for the Pentax Universal Video Scope Hookup (DSD-110-HU0109)...

Name: Z-2213-2010 DSD Application Guide (MG04-0001 revision M) for the Pentax Universal Video Scope Hookup (DSD-110-HU0109)...
Creator: Minntech Corp
Published: 2010-06-15
License: https://open.fda.gov/license/

Medivators Inc / initiated 2010-06-15 / Terminated / root cause: labeling and UDI

FDA source

Minntech Corp began a recall of 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... on 2010-06-15. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2213-2010
Status: Terminated
Initiated: 2010-06-15
Posted: 2010-08-12
Terminated: 2011-12-17
Recalling firm: Medivators Inc
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.
Product code: FEB Accessories, Cleaning, For Endoscope
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
Root cause tag: labeling and UDI
FDA root 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.
Product codes and 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.

Product code FEB

K914145Class IIDsd-91(Tm) Disinfector for Flexible EndoscopesMedivators, Inc. / cleared 1994-02-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)