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U.S. Department of Health and Human Services

Class 2 Device Recall Nautica (GK) Mattress Stretcher

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  Class 2 Device Recall Nautica (GK) Mattress Stretcher see related information
Date Initiated by Firm January 23, 2007
Date Posted August 24, 2008
Recall Status1 Terminated 3 on August 25, 2008
Recall Number Z-1234-2008
Recall Event ID 46383
Product Classification Non-AC powered patient lift - Product Code FSA
Product Nautica (GK) Mattress Stretcher, manufactured by Georg Kramer GES.M.B.H. & CO. KG A-4061 PASCH ING, Neuhauserweg 14 Austria. These mattress stretchers were sold for installation on or as a component of the following patient bath lifts: a) Manufactured by BHM Medical Inc., Magog, QC, Canada J1X 5Y5: Part number 88004051, Nautica Bath Lift System; b) Distributed by Whitehall Manufacturing, P.O. Box 3527, City of Industry, CA 91744, Manufactured by BHM Medical Inc., Canada: Part number 88004051.12, Nautica Bath Lift System
Code Information There are no serial numbers on the GK Mattress Stretchers. The following bath lifts have the affected stretchers: BHM Part Number 88004051, serial number NTCA-040; BHM Part Number 88004051.12, serial numbers NTCA-0197, NTCA-0200, NTCA-0201, NTCA-0225, NTCA-0166, NTCA-0198
Recalling Firm/
Manufacturer		 Arjo, Inc.
50 Gary Ave Ste A
Roselle IL 60172-1684
For Additional Information Contact Ms. Traci Giovenco
630-307-2756
Manufacturer 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.
FDA Determined
Cause 2		 Device Design
Action 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.
Quantity in Commerce 7 units
Distribution Nationwide Distribution --- including states of California, Connecticut, Florida, Mississippi and Texas.
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.
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