ARJO Carendo Multi-Purpose Hygiene Chair; Model BIB2003-01, a non-AC powered patient lift; Manufactured by Arjo Hospital
FDA device recall Z-1946-2009 · posted 2009-09-08 · Terminated
Recall details
- Recalling firm
- ArjoHuntleigh
- 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.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- FSA
- Quantity affected
- 1,987 hygiene chairs
- Distribution
- Nationwide Distribution
- Date initiated
- 2009-06-11
- Date posted
- 2009-09-08
- Date terminated
- 2010-08-19
- Location
- Addison, IL
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