Reported Mar 5, 2014 · Terminated
GE Healthcare - Giraffe Warmer;Panda Warmer;Panda iRes Warmer, Giraffe Stand-alone Infant Resuscitation System. Product…
GE Healthcare, LLC
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Healthcare, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- GE Healthcare - Giraffe Warmer;Panda Warmer;Panda iRes Warmer, Giraffe Stand-alone Infant Resuscitation System
- Product UsageThe 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
- Lot codes and dates
- 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,
99 of 99 codes
QABS50014QABS50111QABS50112QABS50113QABS50114QABS50033QABS50034QABS50035QABS50036QABS50037QABS50038QABS50039QABS50040QABS50041QABS50042QABS50043QABS50044QABS50045QABR50238QABR50239QABR50240QABR50241QABR50242QABR50243QABR50244QABR50245QABR50246QABR50247QABR50248QABR50249QABR50250QABR50251QABR50252QABR50254QABR50255QABR50256QABR50257QABR50258QABR50259QABR50260QABR50261QABR50262QABR50263QABR50264QABR50265QABR50266QABR50267QABR50269QABR50270QABR50271QABR50272QABR50273QABS50046QABS50135QABS50007QABS50009QABS50030QABS50047QABR50120QABR50121
- 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,
- Amount recalled
- 12, 373 units total, 8,807 = US, 3,394 = OUS, 172 = unknown
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
Stop using this product now
Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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