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U.S. Department of Health and Human Services

Class 2 Device Recall Medisafe Distal Duck Kit and Duck Bag (Humidity Pack)

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 Class 2 Device Recall Medisafe Distal Duck Kit and Duck Bag (Humidity Pack)see related information
Date Initiated by FirmNovember 19, 2020
Create DateJanuary 11, 2021
Recall Status1 Terminated 3 on October 25, 2023
Recall NumberZ-0830-2021
Recall Event ID 86906
Product Classification Cleaner, ultrasonic, medical instrument - Product Code FLG
ProductMedisafe 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.
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 
FEI Number 1527821
Recalling Firm/
Manufacturer		 Steris Corporation
5960 Heisley Rd
Mentor OH 44060-1834
For Additional Information ContactCharlie Kilfoyle
800-548-4873
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Device Design
ActionOn 11/23/2020, STERIS issued Urgent Device Correction notices to customers via courier service. Instructing customers to inspect and destroy any remaining affected products in their inventory. STERIS will provide replacement product at no cost to Customers who have product remaining in stock.
Quantity in Commerce23,445 units, Domestic 5,727 units, Foreign 17,718 units
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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