—#184816

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.

FDA product code: FLG — Cleaner, Ultrasonic, Medical Instrument
Device class: Class 1
Medical specialty: General Hospital
Affected lot / code info: 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

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.

Root cause (FDA determination)

Device Design

Action the firm took

On 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.

Recalling firm

Firm: Steris Corporation
Address: 5960 Heisley Rd, Mentor, Ohio 44060-1834

Distribution

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.

Timeline

Recall initiated: 2020-11-19
Terminated: 2023-10-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #184816. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.