Food, drugs, devices › ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Device recall: Concerto & Basic Shower Trolly, Model Numbers BAB1000-01 (UDI: (01)05055982788083), BAB1000CON6102 [(01)05056097364483],
ARJOHUNTLEIGH POLSKA Sp. z.o.o. (Komorniki) initiated this device recall on 22 Aug 2019; FDA lists 1 product record under event 84881, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 968 device enforcement events initiated in 2019 carry the same class.
Status: Terminated, terminated 15 Feb 2022. Initiation: voluntary: firm initiated. ARJOHUNTLEIGH POLSKA Sp. z.o.o. has 9 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
ARJOHUNTLEIGH POLSKA Sp. z.o.o., Komorniki, Poland.
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,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1452-2020 | 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:… | 669 trollys | Class II | Terminated | 18 Mar 2020 |
Context
Other enforcement events for ARJOHUNTLEIGH POLSKA Sp. z.o.o.
All 9 events for ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "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,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 15 Feb 2022. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.