FDA · Medical device recall

GE Healthcare… and 2 more products

March 5, 2014 Class I

Date: March 5, 2014
Risk class: Class I (FDA's definition, 21 CFR 7.3(m): a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death)
Status: Terminated
Filed by: GE Healthcare, LLC
Reason: Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.
Distribution pattern: Worldwide Distribution - USA Nationwide including the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL,GA. HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY; and the countries of Albania, Austria, Australia, Bahrain, Belarus, Belgium, Canada, China, Costa Rica, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Greece, Guatemala, Germany, Honduras, Hong Kong, Hungry, India, Indonesia, Ireland, Italy, Kazakhstan, Korea, Lithuania, Malaysia, Mexico, Netherlands, Norway, Peru, Poland, Romania, Russia, Saudi Arabia, South Africia, Spain, Sweden, Switzerland Turkey, United Arab, United Kingdom, and Venezuela.

3 products in this recall

GE Healthcare…

Product: GE Healthcare - Giraffe Warmer;Panda Warmer;Panda iRes Warmer, Giraffe Stand-alone Infant Resuscitation System. Product Usage: The T-Piece Resuscitation System [ventilator, emergency powered resuscitator]/Panda Bag and Mask Resuscitation System provides the basic equipment required for pulmonary resuscitation of infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures and/or manual ventilation to the infant. These are clinical practices that represent the established standard of care.
Quantity: 12, 373 units total, 8,807 = US, 3,394 = OUS, 172 = unknown
Codes and lots: QABR50042, QABR50036, QABR50082, QABR50110, QABR50111, QABR50031, QABR50008, QABS50107, QABS50108, QABS50139, QABR50009, QABR50043, QABS50017, QABS50072, QABS50129, QABS50076, QABR50005, QABR50060, QABR50035, QABS50084, QABS50100, QABR50038, QABR50023, QABR50095, QABR50097, QABS50151, QABS50153, QABS50154, QABR50137, QABR50144, QABR50002, QABR50001, QABR50015, QABS50119, QABS50122, QABR50112, QABR50129, QABS50098, QABS50099, QABS50101, QABR50124, QABR50141, QABR50028, QABS50148, QABR50109, QABR50030, QABR50217, QABR50159, QABR50160, QABR50161, QABR50163, QABR50165, QABR50166, QABR50167, QABR50172, QABR50173, QABR50174, QABR50175, QABR50176, QABR50177, QABR50178, QABR50179, QABR50180, QABR50181, QABR50182, QABR50183, QABR50184, QABR50185, QABR50186, QABR50187, QABR50188, QABR50189, QABR50190, QABR50191, QABR50192, QABR50193, QABR50195, QABR50209, QABR50211,QABR50212, QABR50213, QABR50214, QABR50216, QABR50219, QABR50220, QABR50222, QABR50223, QABR50224, QABR50225,QABR50232, QABR50233, QABR50234, QABR50235, QABR50236, QABR50237, QABS50120, QABS50130, QABS50132, QABR50218, QABR50221, QABR50019, QABR50032, QABR50139, QABR50142, QABR50164, QABR50194, QABR50198, QABR50199, QABR50130, QABR50046, QABR50025, QABR50058, QABR50059, QABR50033, QABR50039, QABR50061, QABR50062, QABR50063, QABR50006, QABR50048, QABS50052, QABS50053, QABS50067, QABS50028, QABS50050, QABS50051, QABR50047, QABS50083, QABR50020, QABS50025, QABS50029, QABR50016, QABR50169, QABR50170, QABR50171, QABS50071, QABS50118, QABS50147, QABR50040, QABR50044, QABR50078, QABR50084, QABR50150, QABR50231, QABR50014, QABS50077, QABS50078, QABS50079, QABS50134, QABS50140, QABS50131, QABR50208, QABR50210, QABS50018, QABS50019, QABS50150, QABS50149, QABS50160, QABR50041, QABR50022, QABR50017, QABR50010, QABR50012, QABR50136, QABR50138, QABS50024, QABS50048, QABS50049, QABR50135, QABR50143, QABR50145, QABR50146, QABR50147, QABR50162, QABR50196, QABR50197, QABR50200, QABR50201, QABR50003, QABR50051, QABR50052, QABR50057, QABR50096, QABR50098, QABR50099, QABR50081, QABS50020, QABS50016, QABR50134, QABR50080, QABR50083, QABS50117, QABS50141, QABR50148, QABR50151, QABR50152, QABS50061, QABS50062, QABS50105, QABS50136, QABS50075, QABR50115, QABS50152, QABR50054, QABR50029, QABS50142, QABS50143, QABS50095, QABS50097, QABR50055, QABR50094, QABS50064, QABS50065, QABS50066, QABS50080, QABS50081, QABS50082, QABR50114, QABR50027, QABR50056, QABR50131, QABR50037, QABR50007, QABS50133, QABR50215, QABS50121,QABR50140, QABR50034, QABR50024, QABR50079, QABR50049, QABR50050, QABS50073, QABS50074, QABR50011, QABR50125, QABR50018, QABR50026, QABR50004, QABR50113, QABR50168, QABR50053, QABR50077, QABR50085, QABS50015, QABR50045, QABR50013, QABR50021, QABR50149, QABR50153, QABS50031, QABS50032, QABS50058, QABS50059, QABS50060, QABS50063, QABR50203, QABR50204, QABR50093, QABS50106, QABS50123, QABS50124, QABS50125, QABS50126, QABS50137 QABS50138, QABR50205, QABR50207, QABS50104, QABS50022, QABS50055, QABS50056, QABS50057, QABS50128, QABS50096, QABR50202, QABS50014 QABS50111 QABS50112 QABS50113 QABS50114 QABS50033 QABS50034 QABS50035 QABS50036 QABS50037 QABS50038 QABS50039 QABS50040 QABS50041 QABS50042 QABS50043 QABS50044 QABS50045 QABR50238 QABR50239 QABR50240 QABR50241 QABR50242 QABR50243 QABR50244 QABR50245 QABR50246 QABR50247 QABR50248 QABR50249 QABR50250 QABR50251 QABR50252 QABR50254 QABR50255 QABR50256 QABR50257 QABR50258 QABR50259 QABR50260 QABR50261 QABR50262 QABR50263 QABR50264 QABR50265 QABR50266 QABR50267 QABR50269 QABR50270 QABR50271 QABR50272 QABR50273 QABS50046 QABS50135 QABS50007 QABS50009 QABS50030 QABS50047 QABR50120 QABR50121 QABS50085 QABS50144 QABS50145 QABR50127 QABS50087 QABS50088 QABS50089 QABR50128 QABR50154 QABR50155 QABR50156 QABR50157 QABR50158 QABR50268 QABS50109 QABS50110 QABR50226 QABR50228 QABR50227 QABR50229 QABR50253 QABS50001 QABS50002 QABS50003 QABS50004 QABS50005 QABS50006 QABS50008 QABS50010 QABS50011 QABS50012 QABS50013 QABS50068 QABS50090 QABS50091 QABS50092 QABS50093 QABS50094 QABS50127
Recall started: Oct. 1, 2013
Device type: Ventilator, Emergency, Powered (Resuscitator)
Root cause (FDA): Component design/selection
What the company told customers: GE Healthcare sent an Urgent Medical Device Correction letter dated November 18, 2013, with a return receipt to all affected customers. The letter identified the products, the problem, and safety instructions to be taken by the customer along with the product correction. It is recommended that all potential users in your facility are made aware of this safety notification and the recommended actions. Safety issues described the description and affected product details, safety instructions, photos showing the back of the resuscitation system where the Air and Oxygen fittings are located and an appendix of the Affected Product Serial Number Definition and Configurations of Fittings. For questions or concerns regarding this notification, please call the phone number listed below: United States: 1-800-345-2700.
Recall number: Z-1070-2014

GE Healthcare…

Product: GE Healthcare - Giraffe and Panda Bag and Mask Resuscitation System;Giraffe Stand-alone Infant Resuscitation System. Product Usage: The Bag and Mask Resuscitation System provides the basic equipment required for pulmonary resuscitation of infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures and/or manual ventilation to the infant. These are clinical practices that represent the established standard of care.
Quantity: 12, 373 units total, 8,807 = US, 3,394 = OUS, 172 = unknown
Codes and lots: QABS50026, QABR50066, QABR50068, QABR50133, QABS50023, QABR50102, QABR50103, QABR50064, QABR50065, QABR50067, QABS50070, QABS50069, QABR50275, QABS50027, QABR50274
Recall started: Oct. 1, 2013
Device type: Ventilator, Emergency, Manual (Resuscitator)
Root cause (FDA): Component design/selection
What the company told customers: GE Healthcare sent an Urgent Medical Device Correction letter dated November 18, 2013, with a return receipt to all affected customers. The letter identified the products, the problem, and safety instructions to be taken by the customer along with the product correction. It is recommended that all potential users in your facility are made aware of this safety notification and the recommended actions. Safety issues described the description and affected product details, safety instructions, photos showing the back of the resuscitation system where the Air and Oxygen fittings are located and an appendix of the Affected Product Serial Number Definition and Configurations of Fittings. For questions or concerns regarding this notification, please call the phone number listed below: United States: 1-800-345-2700.
Recall number: Z-1071-2014

GE Healthcare…

Product: GE Healthcare - Giraffe¿ and Panda¿ iRes Infant Warmer Product Usage: The infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonates transition to the external environment or to provide a controlled open environment. An optional integrated Sp02 monitoring feature may be used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin and pulse rate.
Quantity: 12, 373 units total, 8,807 = US, 3,394 = OUS, 172 = unknown
Codes and lots: HDJQ52826, HDJR52093, HDJR50704, HDJR54140, HDJR54141, HDJR54142, HDJR54143, HDJQ52878, HDJS50670, HDJS50671,HDJS50672, HDJS50678, HDJS50679, HDJS50681, HDJS50682, HDJS50684, HDJS50686, 208600, 208601, 208610, HDJS51010, HDJR56405, HDJS52316, HDJP51364, HDJP51369, HDJP51376, HDJP51379, HDJP51380, HDJP51381, HDJR56387, HDJR56388, HDJR56389, HDJR56390, HDJR56391, HDJR56666, HDJN50977, HDJN50978, HDJP51983, HDJQ53071, HDJM51282, HDJM51283, HDJM51284, HDJM51285, HDJM51286, HDJM51287, HDJM51288, HDJM51289, HDJM51290, HDJM51291, HDJM51292, HDJM51293, HDJM51294, HDJM51295, HDJQ50845, HDJQ50846, HDJQ50361, HDJQ50362, HDJQ50363, HDJQ50364, HDJQ50365, HDJQ52097, HDJM51403, HDJM51871, HDJP52195, HDJP52198, HDJP52199, HDJP52200, HDJP52201, HDJP52202, HDJP52203, HDJP52204, HDJP52205, HDJP52206, HDJP52207, HDJN52273, HDJN52274, HDJN52275, HDJN52276, HDJP50604, HDJP50605, HDJM50831, HDJM50832, HDJM50833, HDJS51808, HDJM50053, HDJM50054, HDJM50098, HDJM50099, HDJM50101, HDJM50103, HDJM50105, HDJM50124, HDJM50388, HDJP50315, HDJP50369, HDJP50371, HDJR58044, HDJR58045, HDJP51614, HDJP51615, HDJN52372, HDJN52373, HDJS50504, HDJS50505, HDJM50027, HDJL50483, HDJM50022, HDJM50024, HDJM50411, HDJS50708, HDJS52037, HDJR57284, HDJR57285, HDJN52002, HDJN50436, HDJN50437, HDJP50552, HDJP50553, HDJQ50808, HDJP50078, HDJP50083, HDJQ52336, HDJQ52337, HDJQ52036, HDJQ52037, HDJQ52038, HDJQ52039, HDJS51666, HDJP52689, HDJR56613, HDJQ52689, HDJQ51784, HDJQ51785, HDJQ51786, HDJQ51787, HDJS50825, HDJS50826, HDJS50827, HDJS50828, HDJS50829, HDJS50830, HDJS50831, HDJS50832, HDJR56841, HDJR56842, HDJR56843, HDJR56844, HDJR56845, HDJR56846, HDJR56847, HDJR56848, HDJR56849, HDJR56850, HDJR56851, HDJR56852, HDJR56853, HDJS51131, HDJQ52031, HDJQ50663, HDJS50931, HDJS50932, HDJQ51956, HDJM50250, HDJM50251, HDJM50252, HDJM50253, HDJM50254, HDJM50255, HDJM52126, HDJM52127, HDJM52128, HDJM52129, HDJQ50066, HDJQ50067, HDJR50734, HDJR50735, HDJR50762, HDJR50763, HDJR50764, HDJR58093, HDJR58094, HDJR58095, HDJS50028, 206180, HDJR52011, HDJR52012, 206581, HDJR54180, HDJR50307, HDJR50308, HDJR50309, HDJR50310, HDJS51721, HDJP52371, HDJP52558, HDJM51686, HDJM51687, HDJN51900, HDJN51901, HDJP51716, HDJS50570, HDJS50571, HDJS50572, HDJS50573, HDJM50391, HDJM50392, HDJN51693, HDJN51694, HDJR56618, HDJP50523, HDJP50524, HDJP50525, HDJP50526, HDJP50527, HDJP50528, HDJL50044, HDJP50572, HDJP52345, HDJP52349, HDJP52350, HDJQ52153, HDJQ52154, HDJQ52155, HDJQ52156, HDJQ52157, HDJM50520, HDJM50521, HDJM50522, HDJN50060, HDJN50228, HDJN52440, HDJN52444, HDJN52445, HDJN52447, HDJP51831, HDJP51912, HDJP51913, HDJP51914, HDJQ51571, HDJQ51572, HDJR57384, HDJS51672, HDJS51673, HDJS51674, HDJS51675, HDJS52895, HDJP50288, HDJP50289, HDJP50290, HDJP50291, HDJP50292, HDJP50293 HDJP50294 HDJP50295 HDJP50296 HDJP50297 HDJP50298 HDJP50299 HDJP50300 HDJP50301 HDJP50302 HDJP50303 HDJP50304 HDJP50305 HDJP50306 HDJP50307 HDJP50308 HDJP50285 HDJP50286 HDJP50287 HDJM51014 HDJM51015 HDJP50825 HDJS51670 HDJS51671 HDJM51624 HDJM51625 HDJP50184 HDJS52686 HDJS52687 HDJM52321 HDJM52322 HDJR50583 HDJP5031 HDJP5037 HDJQ50506 HDJQ51178 HDJS52005 HDJQ51960 HDJR50545 HDJR50546 HDJR50547 HDJR50548 HDJR50549 HDJR50550 HDJR50551 HDJR50552 HDJR50553 HDJR50554 HDJQ50165 HDJQ50187 HDJQ50246 HDJQ50162 HDJQ50164 HDJS52390 HDJR50593 HDJR50599 HDJS52340 HDJS52341 HDJS52342 HDJS52343 HDJS52344 HDJS52391 HDJP50656 HDJR56736 HDJR56802 HDJS52053 HDJS52272 HDJS52365 HDJM50484 HDJM50485 HDJM50486 HDJM50487 HDJP50599 HDJP50600 HDJP52608 HDJS52246 HDJS52247 HDJS52248 209359 209551 209560 HDJP50428 HDJP50429 HDJP50430 HDJP50431 HDJP50432 HDJP50433 HDJP50434 HDJP50435 HDJP50436 HDJP50437 HDJP50438 HDJP50439 HDJP50440 HDJN52367 HDJN52368 HDJN52369 HDJR54333 HDJR56220 HDJN51334 HDJN51335 HDJN51336 HDJR54276 HDJM50693 HDJM51714 HDJM51716 HDJM51717 HDJM51718 HDJM52096 HDJN52193 HDJN52194 HDJN52195 HDJN52196 HDJN52197 HDJP52562 HDJP52563 HDJP52564 HDJP52565 HDJQ52920 HDJQ52917 HDJQ52918 HDJQ52919 HDJQ52921 HDJQ52922 HDJQ52923 HDJQ52924 HDJQ52925 HDJQ52926 HDJQ52927 HDJQ53075 HDJR56481 HDJR56482 HDJR56486 HDJR56487 HDJR56488 HDJR56489 HDJR56490 HDJR56491 HDJN51083 HDJN51084 HDJN51616 HDJN51617 HDJN51805 HDJN51808 HDJP52219 HDJP52220 HDJR50578 HDJR56358 HDJP50531 HDJP50532 HDJQ51064 HDJP50278 HDJQ52830 HDJR56726 HDJR56107 402055 HDJR56370 HDJR56376 HDJR56377 HDJR56229 HDJR56230 HDJR56231 HDJR56233 HDJR56234 HDJR56235 HDJR56236 HDJR56237 HDJR56238 HDJR56239 HDJR56240 HDJR56241 HDJR56242 HDJR56243 HDJR56244 HDJR56249 HDJR56250 HDJR56292 HDJR56293 HDJR56662 HDJR56664 HDJR56669 HDJR56746 HDJR56747 HDJR56748 HDJQ52579 HDJQ52580 HDJQ52581 HDJQ52582 HDJM51930 HDJM52089 HDJM51937 HDJM51938 HDJM50349 HDJR56195 HDJR56221 HDJM51405 HDJM51470 HDJM51471 HDJM51472 HDJM51475 HDJM51847 HDJN52281 HDJN52282 HDJN52283 HDJN52284 HDJN52285 HDJS51291 HDJS51292 HDJQ52292 HDJR57000 HDJM52240 HDJM52241 HDJM52242 HDJN52389 HDJN52390 HDJN52391 HDJR57046 HDJR57047 HDJR57048 HDJR57179 HDJR57180 HDJL50466 HDJL50467 HDJL50470 HDJL50471 HDJM51513 HDJM51516 HDJM51517 HDJM51518 HDJM51520 HDJM51656 HDJN50066 HDJN50067 HDJP52839 HDJS51735 HDJS52577 HDJR50303 HDJP51148 HDJP50275 HDJP50276 HDJP50277 HDJN50979 HDJM50628 HDJM50629 HDJN51925 HDJM50102 HDJN52374 HDJN52375 HDJS51286 HDJS51287 HDJP50940 HDJP50941 HDJR54064 HDJR54065 HDJR54066 HDJR54067 HDJR54068 HDJR54069 HDJR54070 HDJR54071 HDJR54072 HDJR54074 HDJR54075 HDJR54076 HDJR54078 HDJR54079 HDJR54080 HDJR54081 HDJR54083 HDJR54084 HDJR54073 HDJR54077 HDJR54082 HDJR54085 HDJR54086 HDJR54087 HDJR54088 HDJR54089 HDJR54090 HDJR54091 HDJR54092 HDJR54093 HDJR54094 HDJR54063 HDJR54229 HDJR54236 HDJR50095 HDJR50103 HDJS52184 HDJS52187 HDJS52188 HDJS52189 HDJS52273 HDJS52274 HDJM51609 HDJM51611 HDJN50903 HDJN50904 HDJP51586 HDJQ51060 HDJQ51061 HDJQ51062 HDJQ51063 HDJQ51474 HDJQ51475 HDJQ51476 HDJS52145 HDJS52146 HDJS52147 HDJS52148 HDJS52149 HDJS52150 HDJS52151 201384 201424 454895 201409 HDJM52209 HDJM52210 205060 205078 205079 HDJM52059 HDJQ52171 HDJQ52180 HDJQ52181 HDJQ52182 HDJQ52316 HDJQ52317 HDJQ52460 HDJR50412 HDJR50417 HDJR50418 HDJM50272 HDJQ50711 HDJQ50712 HDJQ50713 HDJQ50714 HDJP52799 HDJP50629 HDJP52157 HDJN51853 HDJS52675 HDJP50491 HDJP50634 HDJP50492 HDJP50493 HDJP50494 HDJP50495 HDJP50496 HDJP50497 HDJP51120 HDJQ51827 HDJR56794 HDJR56795 HDJR56796 HDJR56797 HDJR57018 HDJS50509 HDJS50758 HDJR57504 HDJR57505 HDJN52205 HDJN52206 HDJN52207 HDJR50477 HDJR50486 HDJR50487 HDJR50488 HDJR50489 HDJR50490 HDJR50491 HDJP50011 HDJR57559 HDJR57560 HDJN50226 HDJN50227 HDJP51243 HDJP51244 HDJR57730 HDJM51654 HDJN51016 HDJN50601 HDJM50021 HDJM50023 HDJM50025 HDJM50026 HDJM50028 HDJL50481 HDJL50482 HDJL50484 HDJM50019 HDJM50020 HDJM50443 HDJM50483 HDJQ52812 HDJQ52996 HDJQ52997 HDJQ52998 HDJQ52837 HDJP51644 HDJP51645 HDJS51314 HDJS51315 HDJS51316 HDJS51317 HDJS52096 HDJR50544 HDJR57172 HDJM50694 HDJR57039 HDJR57055 HDJR57057 HDJR57058 HDJR57059 HDJR57356 209808 HDJR50426 HDJP50570 HDJR56925 HDJR56926 HDJR56927 HDJN50048 HDJP50937 HDJQ51829 HDJS50958 HDJS50959 HDJS50960 HDJS50961 HDJS50962 HDJS50963 HDJN51934 HDJP50680 HDJR50688 HDJS52680 205239 HDJM51627 HDJM51632 HDJQ51044 HDJN51776 HDJN51777 HDJN51778 HDJN51795 HDJN51796 HDJQ51257 HDJQ51234 HDJQ51235 HDJQ51236 HDJS50133 HDJS50134 HDJS50135 HDJS50136 HDJS50137 HDJS51969 HDJP52485 HDJR56634 HDJP51415 HDJM51088 HDJM51089 HDJM51090 HDJM51091 HDJM51092 HDJP52690 HDJR56005 HDJR56006 HDJR56007 HDJR56008 HDJQ52549 HDJQ52551 HDJQ52552 HDJQ52553 HDJQ52632 HDJQ52597 HDJQ52598 HDJQ52599 HDJQ52600 HDJQ52601 HDJQ52829 HDJS51428 HDJL50215 200513 200522 HDJM50530 HDJM50531 HDJN50850 HDJS50016 HDJM50704 HDJM50705 HDJM50706 HDJM50707 HDJM50708 HDJM50709 HDJQ53073 HDJR57718 HDJP50352 HDJP50364 HDJP50365 HDJQ52220 HDJQ52225 HDJQ52218 HDJQ52219 HDJQ52222 HDJQ52223 HDJQ52224 HDJQ52226 HDJQ52227 HDJQ52228 HDJQ52229 HDJQ52230 HDJQ52231 HDJQ52232 HDJQ52233 HDJQ52234 HDJQ52235 HDJQ52236 HDJQ52239 HDJQ52240 HDJQ52241 HDJQ52242 HDJQ52267 HDJR58193 HDJR58202 HDJR58204 HDJR58206 HDJS50648 HDJS50649 HDJS50650 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Recall started: Oct. 1, 2013
Device type: Ventilator, Emergency, Powered (Resuscitator)
Root cause (FDA): Component design/selection
What the company told customers: GE Healthcare sent an Urgent Medical Device Correction letter dated November 18, 2013, with a return receipt to all affected customers. The letter identified the products, the problem, and safety instructions to be taken by the customer along with the product correction. It is recommended that all potential users in your facility are made aware of this safety notification and the recommended actions. Safety issues described the description and affected product details, safety instructions, photos showing the back of the resuscitation system where the Air and Oxygen fittings are located and an appendix of the Affected Product Serial Number Definition and Configurations of Fittings. For questions or concerns regarding this notification, please call the phone number listed below: United States: 1-800-345-2700.
Recall number: Z-1072-2014

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement reports, recall numbers Z-1070-2014, Z-1071-2014, Z-1072-2014. The agency record governs; check it and the company before acting.

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