Agency classClass IIOur severity:High FDA (Devices)·Z-1452-2020·Announced 2020-03-18

ARJOHUNTLEIGH Recalls Concerto and Basic Shower Trolleys Due to Safety Catch Failure

ARJOHUNTLEIGH is recalling 669 Concerto and Basic Shower Trolleys because a mechanical failure in the safety catch could cause the side support to open, posing a risk of patient falls and injuries.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (patient falls) where injury has not yet been reported, and the agency classification is Class II without explicit reports of hospitalization or death, fitting the 'High' severity criteria.

Plain-English summary

ARJOHUNTLEIGH POLSKA Sp. z.o.o. is recalling 669 units of the Concerto & Basic Shower Trolly, including specific model numbers and spare parts for the safety catch. The recall affects serial numbers ranging from P0512263 to P0551621, as well as specific individual serial numbers listed in the agency documentation. The devices were distributed in the United States across 15 states and in numerous international locations.

The firm identified that the safety catches on these trolleys may exhibit a mechanical failure, specifically a break in one of the arms of the safety catch. In certain circumstances, this failure may cause the side support to open unintentionally. This malfunction creates a potential risk of a patient falling, which could lead to various types of injuries.

Healthcare facilities and consumers should stop using the affected shower trolleys and contact ARJOHUNTLEIGH for instructions on how to return the devices or obtain replacements. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product: Concerto & Basic Shower Trolly, Model Numbers BAB1000-01 (UDI: (01)05055982788083), BAB1000CON6102 [(01)05056097364483], BAB1007-01 [(01)05055982796255], BAB1101-01 [(01)05055982787949], BAB1102-01 [(01)05055982796156], BAB1103-01 [UDI: (01)05055982796163], BAB1107-01…
Manufacturer: ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Category: Medical Device — Patient Mobility / Showering
Hazard: fall-injury
mechanical-failure
Affected units: 669

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 (11)

Concert & Basic Shower trolleys Serial Numbers: P0512263 to P0551621
P0279164
SEE0643339
SEE0605124
P0249502
SEE045073
SEE0520032
1106000338
SEE0348065
P0422951
P0232526

Distribution

Distributed in 15 states:

Same manufacturer · ARJOHUNTLEIGH POLSKA Sp. z.o.o.

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