CLASS II Device recall · Reported 18 Mar 2020 · FDA Enforcement Report
Concerto & Basic Shower Trolly recalled
Arjohuntleigh Polska Sp. z.o.o is recalling Concerto & Basic Shower Trolly, distributed in 15 states. The recall was initiated on 22 Aug 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1452-2020
- FDA event ID
- 84881
- Recalling firm
- Arjohuntleigh Polska Sp. z.o.o, Komorniki
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Aug 2019
- FDA classified
- 6 Mar 2020
- Reported
- 18 Mar 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 22 Aug 2019 | Recall initiated by company | |
| 6 Mar 2020 | Classified by FDA | +197 days |
| 18 Mar 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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,
Where it was distributed
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
CaliforniaColoradoConnecticutGeorgiaMassachusettsMarylandMichiganNorth CarolinaNew JerseyNew YorkOhioOklahomaTexasVirginiaWisconsin
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Concert & Basic Shower trolleys Serial Numbers: P0512263 to P0551621, P0279164, SEE0643339, SEE0605124,P0249502, SEE045073, SEE0520032, 1106000338, SEE0348065, P0422951, P0232526
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Arjohuntleigh Polska Sp. z.o.o
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