Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall ARJO Carendo MultiPurpose Hygiene Chair

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall ARJO Carendo MultiPurpose Hygiene Chair see related information
Date Initiated by Firm June 11, 2009
Date Posted September 08, 2009
Recall Status1 Terminated 3 on August 19, 2010
Recall Number Z-1946-2009
Recall Event ID 52232
Product Classification Lift, patient, non-ac-powered - Product Code FSA
Product ARJO Carendo Multi-Purpose Hygiene Chair; Model BIB2003-01, a non-AC powered patient lift; Manufactured by Arjo Hospital Equipment AB, Eslov, Sweden.

The equipment is intended for hygiene care, showering, and toileting of
hospital or nursing home residents under the supervision of trained
nursing staff and in accordance with the instructions outlined in the
Operating and Product Care Instructions.
Code Information Model Number: BIB2003-01, all Serial Numbers below 0905000031.
Recalling Firm/
Manufacturer		 ArjoHuntleigh
2349 W Lake St
Addison IL 60101-6183
For Additional Information Contact Ms. Traci Giovenco
800-323-1245
Manufacturer Reason
for Recall		 Male patient genitals may be pinched between the seat and the frame of the patient lift chair when the Care Raiser seat is returned to its lowest position.
FDA Determined
Cause 2		 Device Design
Action ArjoHuntleigh sent Urgent Device Field Correction letters dated June 11, 2009, along with the Urgent Field Safety Notice ID 090526AHE dated May 26, 2009, via UPS Ground delivery. Customers were informed of the affected device and were requested to complete the response form with new contact information and fax it back to ArjoHuntleigh at 630-567-5012 or 630-925-7969. For further questions, contact ArjoHuntleigh at 1-800-323-1245.
Quantity in Commerce 1,987 hygiene chairs
Distribution Nationwide Distribution
Total Product Life Cycle TPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
-
-