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U.S. Department of Health and Human Services

Class 2 Device Recall Heron

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 Class 2 Device Recall Heronsee related information
Date Initiated by FirmJune 30, 2017
Create DateNovember 09, 2018
Recall Status1 Open3, Classified
Recall NumberZ-0441-2019
Recall Event ID 81217
Product Classification Chair, with casters - Product Code INM
ProductHeron toilet and bath chair Model 880505-01 & 880505-11
Code Information Serial Numbers: 309658, 310007, 319209, 319822, 319823, 319824, 319825, 319826, 319827, 319829, 319830, 319831, 330695, 330696, 330697, 331862, 331914, 332387, 332586, 332587, 332589, 333755, 333761, 333762, 334833, 342515, 342518, 342523, 345084, 345085
FEI Number 3001657382
Recalling Firm/
Manufacturer		 R82 A/S
Parallelvej 3
Gedved Denmark
Manufacturer Reason
for Recall		Replacement campaign on all units that have a gas spring head in aluminum.
FDA Determined
Cause 2		Other
ActionThe firm sent a letter ask you to replace the gas spring heads on these Herons  the replacement kits are being sent to your attention. Please carry out the required retrofitting yourself or forward the kits and instructions to those that maintain the product on your behalf. This replacement must take place as soon as you possibly can and no later than 31-12-2017 and the reporting form documenting this must be filled in for each unit and returned to R82 A/S.
Quantity in Commerce687
DistributionNationwide Denmark, Germany, Spain, Finland, France, Great Britain, Island, Netherlands, Norway, Poland, Switzerland, Japan, Australia and New Zealand
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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