Z-0830-2021Class II

Medisafe Distal Duck Kit and Duck Bag, Cleaner, ultrasonic, medical instrument -

Name: Z-0830-2021 Medisafe Distal Duck Kit and Duck Bag, Cleaner, ultrasonic, medical instrument -
Creator: Steris Corporation
Published: 2020-11-19
License: https://open.fda.gov/license/

STERIS Corporation / initiated 2020-11-19 / Terminated / root cause: design

FDA source

Steris Corporation began a recall of Medisafe Distal Duck Kit and Duck Bag, Cleaner, ultrasonic, medical instrument - Product Usage: intended to keep instruments moist during transportation... on 2020-11-19. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0830-2021
Classification: Class II
Status: Terminated
Initiated: 2020-11-19
Posted: 2021-01-11
Terminated: 2023-10-25
Recalling firm: STERIS Corporation
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.
Product code: FLG Cleaner, Ultrasonic, Medical Instrument
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.
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 23,445 units, Domestic 5,727 units, Foreign 17,718 units
Distribution: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0830-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0830-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-20	2021-01-11

Product code FLG

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)