Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0830-2021·Announced 2021-01-20

Steris Recalls Medisafe Distal Duck Kits Due to Bacteria Presence

Steris is recalling specific lots of Medisafe Distal Duck Kits and Bags because they may contain Pseudomonas fluorescens bacteria. The agency notes there is no risk to patients.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states there is no risk to patients and only an improbable risk to users, fitting the criteria for a voluntary precautionary recall with low-risk contamination.

Plain-English summary

Steris Corporation is recalling specific lots of Medisafe Distal Duck Kits and Duck Bags. These products are ultrasonic medical instrument cleaners intended to keep instruments moist during transportation between the point of use and cleaning. The recall affects 23,445 units, with distribution across the United States and numerous international locations including the United Kingdom, Canada, and Australia.

The recall was initiated because Steris identified that certain lots of the diluted 4-Zyme solution contained in these kits may contain bacteria, specifically Pseudomonas fluorescens. The presence of this bacteria can cause the color of the detergent to darken over time. The source text states that there is an improbable risk to users of the product from exposure to this bacteria and explicitly notes there is no risk to patients.

The affected products include Model# M20350, M20358, M20359, and M20400 across various lot numbers listed in the recall documentation. Because the source text indicates no risk to patients and an improbable risk to users, the hazard is considered low. Users should check their product lot numbers against the recall list and contact Steris Corporation for further instructions.

The recalled product

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.
Manufacturer: Steris Corporation
Category: Medical Device — Instrument Reprocessing
Hazard: bacterial-contamination

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

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

Distribution

Distributed nationwide across the United States.

The notice also names 13 states specifically:

Same manufacturer · Steris Corporation

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