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Recall Observatory FDA recall evidence

Device product

Medisafe Distal Duck Kit and Duck Bag, Cleaner, ultrasonic, medical instrument - Product Usage: intended to keep instruments moist during transportation between point of use and cleaning as an initial step of reprocessing.

Z-0830-2021

November 19, 2020

Class II

Product summary

Firm
Steris Corporation
Event
Event 86906
Status
Terminated
Classification
Class II
Quantity
23,445 units, Domestic 5,727 units, Foreign 17,718 units
Official record key
device-enforcement:Z-0830-2021

Official wording

Reason: STERIS has identified that certain lots of diluted 4-Zyme may contain bacteria, specifically Pseudomonas fluorescens. The presence of this bacteria can cause the color of the detergent to darken over time. There is an improbable risk to users of the product from exposure to this bacteria, and no risk to patients.

Code information: Model# M20350 Lot# 1811273,1811277,1906484,1908593,1909635,1910651, 1911658,2001730,2004770 Model# M20358 Lot# 1903408,1906508,1907556,1909644,2001718,2004772 Model# M20359 Lot# 1811278,1906499,1910649,1911680,1911691,1912708, 2001719,2004768 Model# M20400 Lot# 1901340,1901349,1902374,1904448,1904464,1905505, 1906529,1907571,1908595,1909624,1910653,1912700, 2001717,2004766,2004774,2006797

Distribution pattern: Worldwide distribution - US Nationwide distribution including in the states of CA, DE, CO, VA, FL, WA, TX, OH, PA, MA, IA, CT and the countries of United Kingdom, Saudi Arabia, Portugal, Denmark, Ireland, United Arab Emirates, South Korea, Australia, Greece, Ashmore & Cartier Islands, Belgium, Canada, China, Germany, Japan, Norway, Poland, Qatar, Romania, Sweden, Thailand.

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    Pseudomonas fluorescens. The presence