Reported Jan 20, 2021 · Terminated
Medisafe Distal Duck Kit and Duck Bag, Cleaner, ultrasonic, medical instrument - Product Usage: intended to keep…
Steris Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Steris Corporation · 5960 Heisley Rd · Mentor, OH · 44060-1834
Is this the product you have?
- Medisafe Distal Duck Kit and Duck Bag, Cleaner, ultrasonic
- medical instrument - Product Usageintended to keep instruments moist during transportation between point of use and cleaning as an initial step of reprocessing
- Lot codes and dates
8 of 8 products
Products covered by this recall Model / number Product as published M20350— — Lot# 1811273,1811277,1906484,1908593,1909635,1910651, 1911658,2001730,2004770 M20358— — Lot# 1903408,1906508,1907556,1909644,2001718,2004772 M20359— — Lot# 1811278,1906499,1910649,1911680,1911691,1912708, 2001719,2004768 M20400— — Lot# 1901340,1901349,1902374,1904448,1904464,1905505, 1906529,1907571,1908595,1909624,1910653,1912700, 2001717,2004766,2004774,2006797 - Amount recalled
- 23,445 units, Domestic 5,727 units, Foreign 17,718 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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