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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Field Correction - Medi-Temp III, Blood and Fluid Warmer-Gaymar Industries, Inc.

DATE FIELD-CORRECTION INITIATED:

February 14, 2006

PRODUCT / SERIAL NUMBER:
Medi-Temp III, Blood and Fluid Warmer, Model Number FW600

 

A20001, A20002, A20003, A20004, A20005, A20006, A20007, A20008, A20009, A20010, A20011, A20012, A20013, A20014, A30002, A30003, A30004, A30005, A30006, A30007, A30008, A30009, A30010, A30011, A30012, A30013, A30014, A30015, A30016, A30017, A30018, A30019, A30020, A30021, A30022, A30023, A30024, A30025, A30027, A30030, A30031, A40001, A40002, A40003, A40004, A40005, A40006, A40007, A40008, A40009, B20001, B20002, B20003, B20004, B20005, B20006, B20007, B20008, B20009, B20010, B20011, B20012, B20013, B20014, B20015, B20016, B20017, B20018, B20020, B20021, B20022, B20023, B20024, B20025, B20026, B20027, B20028, B20029, B20030, B20031, B20032, B20033, B20034, B20035, B20036, B20037, B20038, B20039, B20040, B20043, B20044, B20045, B20046, B20047, B20048, B20049, B20050, B20051, B20052, B20053, B20054, B20055, B20056, B20057, B20058, B20059, B20060, B20061, B20062, B20063, B20064, B20065, B20066, B30001, B30002, B30003, B30004, B30005, B30006, B30007, B30008, B30009, B30010, B30012, B30013, B30014, B30015, B30016, B30017, B30018, B30019, B30020, B30021, B30022, B30023, B30024, B30025, B30026, B30027, B30028, B30029, B30030, C20002, C20003, C20004, C20005, C20006, C20007, C20008, C20009, C20010, C20011, C20012, C20013, C20014, C20015, C20016, C20017, C20018, C20019, C20020, C20021, C20022, C20023, C20024, C20025, C20026, C20027, C20028, C20029, C20030, C20031, C20032, C20033, C20034, C20036, C20037, C20038, C20039, C20041, C20042, C20043, C20044, C20045, C20046, C20047, C20049, C20050, C20051, C20053, C20054, C20055, C20056, C20057, C20058, C20059, C20060, C30001, C30002, C30003, C30004, C30005, C30006, C30007, C30008, C30009, C30010, C30011, C30012, C30013, C30014, C30015, C30016, C30017, C30018, C30019, C30020, C30021, C30022, C30023, C30024, C30025, C30026, C30027, C30028, C30029, C30030, C30031, C30032, C30033, C30034, C30035, C30036, C30037, C30038, C30039, C30040, C30041, C30042, C30043, C30044, C30045, C30046, C30047, C30048, C30049, C30050, C30051, C30052, C30053, C30054, C30055, C30056, C30057, C30058, C30059, C30060, C40001, C40002, C40003, C40004, C40005, C40006, C40007, C40008, C40009, C40010, C40011, C40012, C40013, C40014, C40015, C40016, C40017, C40018, C40019, C40020, C40021, C40022, C40023, C40024, C40025, C40026, C40027, C40028, C40029, C40030, C40031, C40032, C40033, C40034, C40035, C40036, C40037, C40038, C40039, C40040, C40041, C40042, C40043, C40044, C40045, C40046, C40047, C40048, C40049, C40050, C40051, C40052, C40053, C40054, C40055, C40056, C40057, C40058, C40059, C40061, C40062, C40063, C40064, C40065, C40066, C40067, C40068, C40069, C40070, C40071, C40072, C40073, C40074, C40075, C40076, C40077, C40078, C40079, C40080, C40081, C40082, C40083, C40084, C40085, C40086, C40087, C40088, C40089, C40090, C40091, C40092, C40093, C40094, C40095, C40096, C40097, C40098, C40099, C40100, C40101, C40102, C40103, C40104, C40105, C40106, C40107, C40108, C40109, C40110, C40111, C40112, C40113, C40114, C40115, C40116, C40117, C40118, C40119, C40120, C40121, C40122, C40123, C40124, C40125, C40126, C40127, C40128, C40129, D30001, D30002, D30003, D30004, D30005, D30006, D30007, D30008, D30009, D30010, D30011, D30012, D30013, D30014, D30015, D30016, D30017, D30018, D30019, D30020, D30021, E20001, E20002, E20004, E20005, E20007, E20008, E20009, E20010, E20011, E20012, E20017, E20018, E20019, E20020, E20021, E20022, E20024, E20025, E20027, E20028, E20030, E20031, E20032, E20033, E30002, E30003, E30004, E30005, E30006, E30007, E30009, E30010, E30011, E30012, E30013, E30014, E30015, E30016, E30017, E30018, E30019, E30020, E30021, F20001, F20002, F20003, F20004, F20005, F20006, F20007, F20008, F20009, F20010, F20011, F20012, F20013, F20014, F20015, F20016, F20017, F20018, F20019, F20020, F20021, F20022, F20023, F20024, F20025, F20027, F20028, F20029, F20030, F20031, F20032, F20033, F20034, F20035, F20036, F20037, F20038, F20039, F20040, F20041, F20042, F20043, F20044, F20045, F20046, F20047, F20048, F20049, F20050, F20051, F20052, F20053, F20054, F20055, F20056, F20057, F20058, F20059, F20060, F20061, F20062, F20063, F20064, F20065, F20066, F20067, F20068, F20069, F20070, F20071, F20072, F20073, F20074, F20076, F20077, F20078, F20080, F20081, F20082, F20083, F20084, F20085, F20086, F20087, F20088, F20089, F20090, F20091, F20092, F20093, F20094, F20095, F20096, F20097, F20098, F20099, F20101, F20102, F20103, F30001, F30002, F30003, F30004, F30005, F30006, F30007, F30008, F30009, F30010, F30011, F30012, F30013, F30014, F30015, F30016, F30017, F30018, F30020, F30021, F30022, F30023, F30025, F30026, F30027, F30028, F30029, F30030, F30031, F30032, F30033, F30034, F30035, F30036, F30037, F30038, F30039, F30040, F30041, F30042, F30043, F30044, F30045, F30047, F30048, F30050, F30052, F30053, F30054, F30056, F30057, F30058, F30059, F30060, F30061, F30062, F30063, F30064, F30066, F30067, F30068, F30069, F30070, F30071, F30072, F30073, F30074, F30076, F30077, F30078, F30079, F30081, F30082, F30083, F30084, F30086, F30087, F30088, F30089, F30090, F30091, F30092, F30093, F30094, F30095, F30096, F30097, G20001, G20002, G20003, G20004, G20005, G20006, G20007, G20008, G20009, G20010, G20011, G20012, G20013, G20014, G20015, G20016, G20017, G20018, G20019, G20020, G20021, G20022, G20023, G20024, G20025, G20026, G20027, G20028, G30001, G30002, G30003, G30004, G30005, G30006, G30007, G30008, G30009, G30010, G30011, G30012, G30013, G30014, G30015, G30016, G30017, G30018, G30019, G30020, G30021, G30022, G30023, G30024, G30025, G30026, G30027, G30028, G30029, G30030, G30031, G30032, G30033, G30034, G30035, G30036, G30037, G30038, G30039, G30040, G30041, G30042, H20001, H20002, H20003, H20004, H20005, H20006, H20007, H20008, H20009, H20010, H20011, H20016, H20017, H20018, H20019, H20020, H20021, H20022, H20023, H20024, H30001, H30002, H30003, H30004, H30005, H30006, H30007, H30008, H30010, H30011, H30012, H30013, H30014, H30015, H30016, H30017, H30018, H30019, H30020, H30022, H30023, H30024, H30025, H30026, H30027, H30028, H30029, H30030, H30031, H30032, H30033, H30034, H30035, H30036, H30037, H30038, H30039, H30040, H30041, H30042, H30043, H30044, H30045, H30046, H30047, H30048, H30049, H30050, H30051, H30052, H30053, H30054, H30055, H30056, H30057, H30058, H30059, H30060, H30061, H30062, H30063, H30064, H30065, H30066, H30067, H30068, H30069, H30070, H30071, H30072, H30073, I20001, I20002, I20003, I20005, I20007, I20008, I20009, I20010, I20011, I20012, I20013, I20014, I20016, I20017, I20018, I20019, I20020, I20021, I20022, I20023, I20024, I20025, I20026, I20027, I20028, I20029, I20030, I20031, I20032, I20033, I20035, I20036, I20037, I30001, I30002, I30003, I30004, I30005, I30006, I30007, I30008, I30009, I30010, I30011, I30012, I30013, I30014, I30015, I30016, I30017, I30019, I30020, I30021, I30022, I30023, I30024, I30025, I30026, I30027, J20001, J20002, J20003, J20004, J20005, J20006, J20007, J20008, J20009, J20010, J20011, J20012, J20013, J20014, J20015, J20016, J20017, J20018, J20019, J20020, J20021, J20022, J20023, J20024, J20025, J20026, J20027, J20028, J20029, J20030, J20031, J20032, J20033, J20034, J20035, J20036, J20037, J20038, J20039, J20040, J20042, J20043, J20044, J20045, J20048, J20049, J20050, J20051, J20052, J30001, J30002, J30003, J30004, J30006, J30007, J30008, J30009, J30010, J30011, J30012, J30013, J30014, J30015, J30016, J30017, J30020, J30021, J30022, J30023, J30024, J30025, J30026, J30027, J30028, J30029, J30030, J30031, J30032, J30033, J30034, J30035, J30036, J30037, J30038, J30039, J30040, J30041, J30042, J30043, J30044, J30045, J30046, J30047, J30048, J30049, J30050, J30051, J30052, J30053, J30054, J30055, J30056, J30057, J30058, J30059, J30060, J30061, J30062, J30063, J30064, J30065, J30066, J30067, J30068, J30069, J30070, J30071, J30072, J30073, J30074, J30075, J30076, J30077, J30079, J30080, J30081, J30082, K10003, L10001, L20001, L20002, L20004, L20005, L20006, L20007, L20008, L20009, L20011, L20012, L20013, L20014, L20016, L20017, L20018, L20019, L20020, L20021, L20022, L20023, L20024, L20025, L20026, L20027, L20028, L20029, L20030

 

Medi-Temp III, Blood and Fluid Warmer, Model Number FW601

 

C40001, C40002, C40003, C40004, C40005, C40006, D40001, D40002, D40003, D40004, D40005, D40006, D40007, D40008, D40009, D40010, D40011, D40012, D40013, D40014, D40015, D40016, D40017, D40018, D40019, D40020

Medi-Temp III, Blood and Fluid Warmer, Model Number FW603

A20001, A20002, A20003, A20004, A20005, A20006, A20007, A20008, A20009, A20010, A20011, A20012, A20013, A20014, A20015, A20016, A20017, A20018, A20019, A20020, A20021, A20022, A20023, A20024, A20025, A20026, A20027, A20028, A20029, A20030, A20031, A20032, A20033, A20034, A20035, A20036, A20037, A30001, A30002, A30003, A30004, A30005, A30006, A30007, A30008, A30009, A30012, A30013, A30014, A30015, A30016, A30017, A30018, A30019, A30020, A30026, A30027, A30028, A30029, A30030, A30031, A30032, A30033, A30034, A30040, A30041, A30042, A30043, A30044, A30045, A30046, A30047, A30048, A30051, A30052, A30053, A30055, A30056, A30057, A30058, A30059, A30060, A30061, A30062, A30063, A30064, A40001, A40002, A40003, A40004, A40005, A40006, A40007, A40008, A40009, A40010, A40011, A40012, A40013, A40014, A40015, A40016, A40017, A40018, A40019, A40020, A40021, A40022, A40023, A40024, A40025, A40026, A40027, A40028, A40029, A40030, B20001, B20002, B20003, B20004, B20005, B20006, B20007, B20008, B20009, B20010, B20011, B20012, B20013, B20014, B30001, B30002, B30003, B30004, B30005, B30006, B30007, B30008, B30009, B30010, B30011, B30012, B30013, B30014, B30015, B30016, B30017, B30018, B30020, B30021, B30022, C20001, C20002, C20003, C20004, C20005, C20006, C20007, C20008, C20009, C20010, C20011, C20012, C20013, C20014, C20015, C20016, C30001, C30002, C30003, C30004, C30005, C30006, C30007, C30008, C30009, C30010, C30011, C30012, C30013, C30014, C30015, C30016, C30017, C30018, C30019, C30021, D30001, D30002, D30005, D30006, D30007, D30008, D30009, D30010, D30011, D30012, D30013, D30014, D30015, D30016, D30017, D30018, D30019, D30020, D30026, D30027, D40001, D40002, D40003, D40004, D40005, D40006, D40007, D40008, D40009, D40010, D40011, D40012, D40013, D40014, D40015, D40016, D40017, D40018, D40019, D40020, D40021, D40022, D40023, D40024, D40025, D40026, D40027, E20001, E20002, E20003, E20004, E30001, E30002, E30003, E30004, E30005, E30006, E30007, E30008, E30009, E30010, E30011, E30012, E30013, E30014, E30015, E30016, E30017, E30018, E30019, E30020, E30021, F20001, F20002, F20003, F20004, F20005, F20006, F20007, F20008, F20009, F20010, F20011, F20012, F20013, F20014, F30001, F30002, F30003, F30004, F30005, F30006, F30007, F30008, F30009, F30010, F30011, F30012, F30013, F30014, F30015, F30016, F30017, F30018, F30019, F30020, G20001, G20002, G20003, G20004, G20005, G20006, G20007, G20008, G20009, G20010, G20011, G20012, G20013, G20014, G20015, G20016, G20017, G20018, G20019, G20020, G30001, G30002, G30003, G30004, G30005, G30006, G30007, G30008, G30009, G30010, H20001, H20002, H20003, H20004, H20005, H20006, H20007, H20008, H20009, H20010, H20011, H20012, H20013, I20001, I20002, I20003, I20004, I20005, I20006, I20007, I20008, I20009, I20010, I20011, I20012, I20013, I20014, I20015, I20016, I20017, I20018, I20019, I20020, I20021, I20022, I20023, I30001, I30002, I30003, I30004, I30005, I30006, I30007, I30008, I30009, I30010, I30011, I30012, I30013, I30014, I30015, I30016, I30017, I30018, I30019, I30020, I30021, I30022, I30023, I30024, I30025, I30026, I30027, I30027, I30028, I30029, I30030, I30031, I30032, I30033, I30034, I30035, I30036, K10001, K10002, K10003, L20001, L20002, L20003, L20004, L20005, L20006, L20007, L20008, L20009, L20010, L20011, L20012, L20013, L20014, L20015, L20016, L20017, L20018, L20019, L20020, L20021, L20022, L20023, L20024, L20025, L20026, L20027, L20028, L20029, L30001, L30002, L30003, L30004, L30005, L30006, L30007, L30008, L30009, L30010, L30011, L30012

 

MANUFACTURER:

Gaymar Industries, Inc.
Orchard Park, New York

REASON:

Gaymar Industries has discovered that blood warmers manufactured prior to April 1, 2004, may have a defective label on the front panel of the unit. In rare cases, this label may allow fluid ingress into the electronics compartment of the warmer should fluid drip or be spilled on the top of the unit.

 

Contact FDA

(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448