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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84881

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
August 22, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
ARJOHUNTLEIGH POLSKA Sp. z.o.o.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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,

Z-1452-2020
Recall number
Z-1452-2020
Initiated
August 22, 2019
Classification
Class II
Status
Terminated
Quantity
669 trollys

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

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