Reported Mar 18, 2020 · Terminated

Concerto & Basic Shower Trolly, Model Numbers BAB1000-01 (UDI: (01)05055982788083), BAB1000CON6102…

ARJOHUNTLEIGH POLSKA Sp. z.o.o.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: ARJOHUNTLEIGH POLSKA Sp. z.o.o. · Ui. Ks. Piotra Wawrzyniaka 2 · Komorniki · N/A

Is this the product you have?

  • 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
Lot codes and dates
  • Concert &
  • Basic Shower trolleys Serial Numbers
    • P0512263 to P0551621
    • P0279164
    • SEE0643339
    • SEE0605124
    • P0249502
    • SEE045073
    • SEE0520032
    • 1106000338
    • SEE0348065
    • P0422951
    • P0232526
Amount recalled
669 trollys

Where it was sold

Why it was 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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Feb 15, 2022 · Data as of Sep 19, 6:51 PM UTC

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