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U.S. Department of Health and Human Services

Class 2 Device Recall Wheeled Ambulance Stretchers

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 Class 2 Recall
Wheeled Ambulance Stretchers
see related information
Date Posted September 11, 2008
Recall Status1 Open
Recall Number Z-1859-2008
Recall Event ID 48146
Product Classification Stretcher, Wheeled - Product Code FPO
Product Model 35A Series Mobile Transporters is an ambulance stretcher for patient transport.
Code Information The following Models within the 35A series were subject to recall: (35-A, 35-AST, 35-A+, 35ITA, 35-ITDS, 35-ANM, 35-A+ST, 35-SL, 35-ITIB, 35-L). The following Serial Numbers were subject to recall: SERIAL 07047767 07047768 07047769 07047770 07047771 07048489 07049108 07049109 07049111 07049112 07049113 07049114 07049115 07049116 07049118 07049119 07049120 07049122 07049123 07049124 07049166 07049167 07049168 07049169 07049170 07049171 07049172 07049173 07049174 07049175 07049176 07049177 07049178 07049179 07049180 07049181 07049182 07049183 07049723 07049724 07049726 07049727 07049728 07049729 07049730 07049731 07049732 07049733 07049734 07049735 07049736 07049737 07049775 07049776 07049777 07049778 07049779 07049780 07049781 07049782 07049783 07049784 07050473 07050474 07050475 07050476 07050477 07050478 07050479 07050480 07050481 07050482 07050483 07050484 07050485 07050486 07050487 07050488 07050489 07050490 07050491 07050492 07050493 07050494 07050495 07050496 07050497 07050564 07050565 07050566 07051124 07051144 07051145 07051146 07051147 07051148 07051149 07051150 07051151 07051152 07051153 07051154 07051155 07051156 07051157 07051158 07051159 07051160 07051161 07051162 07051163 07051878 07051879 07051880 07051881 07051882 07051883 07051884 07051885 07051886 07051887 07051928 07051929 07051930 07051931 07051932 07051933 07051935 07051936 07051937 07051938 07051939 07051940 07051941 07051942 07051943 07051944 07051945 07051946 07051947 07052491 07052492 07052493 07052494 07052495 07052496 07052497 07052498 07052499 07052500 07052501 07052502 07052503 07052504 07052543 07052544 07052545 07052546 07052547 07052548 07052549 07052550 07052551 07052552 07052553 07052554 07052555 07052556 07052557 07052639 07052693 07053218 07053219 07053220 07053221 07053222 07053223 07053258 07053259 07053260 07053261 07053262 07053263 07053264 07053265 07053266 07053267 07053268 07053269 07053270 07053271 07053272 07053273 07053274 07053275 07053276 07053277 07053278 07054057 07054059 07054060 07054071 07054074 07055360 07055361 07055364 07055365 07055366 07055367 07055368 07055953 07055958 07055960 07055964 07055965 07055966 07055967 07056805 07056807 07056808 07056809 07056810 07056811 07056812 07056813 07056814 07056815 07056816 07056817 07056818 07056819 07056820 07056821 07056822 07056823 07056824 07056825 07056826 07056827 07057297 07057298 07057301 07057302 07057303 07057304 07057305 07057306 07057308 07057309 07057310 07057311 07057314 07057317 07057321 07057322 07057323 07057966 07058028 07058617 07058620 07058626 07058673 07058676 07059925 07059928 07059929 07059931 07059932 07059933 07059934 07059935 07059938 07059939 07060434 07060435 07060437 07060438 07060439 07060440 07060441 07060442 07060449 07060457 07060459 07060460 07060461 07060462 07060463 07060464 07060465 07060466 07060467 07061019 07061020 07061029 07061030 07061031 07061039 07061040 07061041 07061042 07061043 07061046 07061047 07061049 07061050 07061051 07061052 07061059 07061060 07061067 07061068 07061069 07061070 07061072 07061073 07061074 07061075 07061076 07061077 07061078 07061086 07061087 07061089 07061090 07061091 07061092 07061093 07061094 07061097 07061098 07061101 07061103 07061104 07061105 07061106 07061107 07061114 07061115 07061116 07061118 07061173 07061712 07061713 07061714 07061715 07061716 07061717 07061718 07061720 07061721 07061722 07061723 07061724 07061725 07061726 07061727 07061728 07061729 07061730 07061733 07061735 07061736 07061737 07061738 07061739 07061740 07061742 07061745 07061747 07061748 07061749 07061750 07061751 07061752 07061753 07061759 07061760 07061761 07061762 07061763 07061764 07061767 07061768 07061769 07061771 07062345 07062346 07062347 07062348 07062349 07062350 07062351 07062352 07062353 07062354 07062355 07062356 07062357 07062358 07062359 07062360 07062361 07062362 07062363 07062364 07062365 07062368 07062369 07062370 07062371 07062372 07062373 07062374 07062381 07062382 07062383 07062384 07062564 07062565 07062577 07063284 07063285 07065704 07065705 07065706 07066543 07066544 07066545 07066546 07066547 07066548 07066549 07067804 07067805 08069464 08069465 08071534 08071535 08071536 08071537 08071553 08071554 08071555 08073210 08073211 08073212 08073213 08073214 08073215 08073216 08073217 08073218 08073219 08074231 08074232 08074233 08074234 08074235 08074236 888113814 888113815 888113816 888113817 888113818 888113819 888113820 888113821 888113822 888113823 888113824 888113825 888113826 888113827 888113828 888113829 888113830 888113831 888113832 BBB113833 BBB113834 BBB113835 8BB113836 BBB113837 BBB113838 BBB113839 BBB113840 BBB113841 BBB113842 BBB113843 BBB113844 BBB113845 BBB113846 BBB113847 BBB113848 BBB113849 BBB113850 BBB113851 BBB113852 BBB113853 BBB113854 BB8113855, and 8BB113856
Recalling Firm/
Manufacturer
Ferno-Washington Inc
70 Weil Way
Wilmington, Ohio 45177-9371
Manufacturer Reason
for Recall
A component defect was found in corner castings of the firm's wheeled ambulance stretchers. Some corner castings on the stretchers were found to be over-sized. Using an over-sized cone-shaped hole corner casting with an improperly seated shank pin could put undue stress on the top screw, possibly causing the screw securing a wheel to become loose or break and the wheel to detach from the stretcher
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components
Action The firm sent an 'Urgent Field Correction' notification letter to their customers, via certified mail on 5/16/2008. The letter instructs the customers to examine all inventory of Model 35A stretchers. The letter also recommends that any identified unit be removed from service until the unit has been inspected by the customer and a field correction completed, if applicable. Once the inspection of the unit(s) has been completed by the customer, they are to contact the firm immediately and inform them of the results of t their inspections. In the event that a casting fails inspection, the customer is instructed to contact Ferno's Technical Support Div. in order to arrange for a casting replacement. To report the results of their inspection(s) or to address any questions or concerns which the customer may have, contact Ferno Technical Support at 1-866-987-3776 or send an email to Quality.Products@ferno.com.
Quantity in Commerce 783 units
Distribution The recalled product was distributed to customers in the following location nationwide: AK, AL, AR, CA, CO, CT, DE, FL, GA, HI, IL, IN, KY, LA, MA, MD, ME, MI, MN, MS, NC, NJ, NM, NY, OH, OK, PA, SC, TN, TX, VA, WI, and WV.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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