ARJOHUNTLEIGH POLSKA Sp. z.o.o.: Medical Device Recall in 2020 - (Recall #: Z-1452-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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,

Product Classification:

Class II

Date Initiated: August 22, 2019

Date Posted: March 18, 2020

Recall Number: Z-1452-2020

Event ID: 84881

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.

Status: Terminated

Product Quantity: 669 trollys

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated