Nautica (GK) Mattress Stretcher, manufactured by Georg Kramer GES.M.B.H. & CO. KG A-4061 PASCH ING, Neuhauserweg 14 Aust

FDA device recall Z-1234-2008 · posted 2008-08-24 · Terminated

Recall details

Recalling firm

Arjo, Inc.

Reason for recall

Repeated use of the ratchets that lock the position of the back and leg rest of the stretcher may damage the retention pin that prevents the latch from disengaging from the anchor system. This would allow the backrest to pivot freely down to the floor.

Action taken

BHM Medical initially notified the end users on 1/23/07 of the potential for the back and leg rest latch ratchets to become damaged, allowing the rests to pivot freely. Should a patient be in the stretcher at the time, the patient could fall, potentially sustaining cuts, bruises or even more severe injuries. The letters provided safety instructions to follow until a permanent fix is available, and requested the accounts to complete and return the enclosed response form acknowledging receipt of the letter and dissemination of the safety instructions to all employees operating the lifts with the affected GK stretchers. BHM sent Customer Field Correction Notification letters dated 1/23/08 to the accounts, along with the Technical Advisory Notice - TAN A dated 1/3/08, reiterating the safety instructions from the 1/23/07 letter and requesting the accounts to, if at all possible, remove the equipment from service until an authorized engineer can replace the ratchets in the backrest and leg rest latches. All consignees have been contacted.

Root cause

Device Design

Status

Terminated

Product code

FSA

Quantity affected

7 units

Distribution

Nationwide Distribution --- including states of California, Connecticut, Florida, Mississippi and Texas.

Date initiated

2007-01-23

Date posted

2008-08-24

Date terminated

2008-08-25

Location

Roselle, IL