# FDA recall Z-1452-2020

> **ARJOHUNTLEIGH POLSKA Sp. z.o.o.** · Class II · device recall initiated 2019-08-22.

## 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 [(01)05055982796187], BAB2000-01 [UDI: (01)05055982788106], BAB2101-01 [(01)05055982788007], BAB2102-01 [01)05055982796194], BAB3000-01 [(01)05055982788120], BAB3101-01 [(01)05055982788021], BAB3107-01[ (01)05055982796248], BAB5000-01 [UDI: (01)05055982788144]. and     Concerto & Basic Shower Trolley Spare parts (safety catch) part no. 8451622, 8546608, S8533571-031, S8533572-031, S8533570-031 S8542201-014, S8523559-031,

## Reason for recall

The firm has become aware that any of the 4 safety catches may exhibit a mechanical failure (break in one of the arms of safety catch), which in certain circumstances may contribute to the side support unintentionally opening and may lead to a potential risk of a  patient fall. The patient falling could lead to various types of   injuries.

## Distribution

US: CA, CO, CT, GA, MA, MD, MI, NC, NJ, NY, OH, OK, TX, VA, WI  OUS: Australia Austria, Bangladesh, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Iceland, India, Ireland, Italy, Japan, Korea, Luxembourg, Netherlands, Netherlands/CW, New Zealand, Norway, Philippines, Poland, Romaina, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Province of China, United Arab Emirates, United Kingdom

## Key facts

- **Recall number:** Z-1452-2020
- **Recalling firm:** ARJOHUNTLEIGH POLSKA Sp. z.o.o.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-08-22
- **Report date:** 2020-03-18
- **Termination date:** 2022-02-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Komorniki, Poland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1452-2020

## Citation

> AI Analytics. FDA recall Z-1452-2020. Retrieved 2026-07-19 from https://api.ai-analytics.org/recall/Z-1452-2020. Source: US FDA. Licensed CC0.

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