Recall Z-1452-2020— ARJOHUNTLEIGH POLSKA Sp. z.o.o.

Class II FDA medical device recall by ARJOHUNTLEIGH POLSKA Sp. z.o.o., initiated 2019-08-22, terminated 2022-02-15. FDA's recall record names no specific 510(k) clearance for this event. 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: 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..

Recalling firm

ARJOHUNTLEIGH POLSKA Sp. z.o.o.

Classification

Class II

Status

Terminated

Initiated

2019-08-22

Terminated

2022-02-15

Firm location

Komorniki, Poland

Data sourced from openFDA. This site is unofficial and independent of the FDA.