lnvacare Precise Rx Pediatric Flowmeter Model Number: IRCPF16. Packed one per carton. The lnvaca...
FDA Device Recall #Z-2364-2016 — Class II — June 21, 2016
Recall Summary
| Recall Number | Z-2364-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 21, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Invacare Corporation |
| Location | Elyria, OH |
| Product Type | Devices |
| Quantity | 395 |
Product Description
lnvacare Precise Rx Pediatric Flowmeter Model Number: IRCPF16. Packed one per carton. The lnvacare Precise Rx Pediatric Flowmeter adapts to lnvacare Concentrators for low-flow usage.The gauge has a scale printed on the front side and the back side. The front scale is the primary source for monitoring oxygen flow. The rear scale is an aide for monitoring oxygen flow.
Reason for Recall
The rear gradation scale was screen printed upside down on the flowmeter gauge.
Distribution Pattern
Worldwide Distribution - US to CA, CO, CT, FL, GA, IA, ID, IL,IN,KS,KY,LA,MA,MD,MI,MS,MT,NC,NE,NJ,NM,NY,OH,PA,SC, TN,TX,UT,VA,WA and Internationally to Canada, Germany and New Zealand.
Lot / Code Information
Serial numbers for Model IRCPF16: 16BF023724, 16BF023729, 16BF023734, 16BF023739, 16BF023744,16BF023720, 16BF023725, 16BF023730, 16BF023735, 16BF023740, 16BF023745,16BF023721, 16BF023726, 16BF023731, 16BF023736, 16BF023741, 16BF023746,16BF023722, 16BF023727, 16BF023732, 16BF023737, 16BF023742, 16BF023747,16BF023723, 16BF023728, 16BF023733, 16BF023738, 16BF023743, 16BF023748,16BF023749, 16BF030593, 16CF015205, 16CF019539, 16CF026064, 16CF030100,16BF023750, 16BF030594, 16CF015206, 16CF019540, 16CF026065, 16CF030101,16BF023751, 16CF016169, 16CF015207, 16CF019541, 16CF026066, 16CF030102,16BF023752, 16CF016170, 16CF015208, 16CF019542, 16CF026067, 16CF030103,16BF023753, 16CF016171, 16CF015209, 16CF019543, 16CF026068,16CF030104,16BF023754, 16CF016172, 16CF015210, 16CF019544, 16CF026069, 16CF030105,16BF023755, 16CF016173, 16CFOI5211, 16CF019545, 16CF026070, 16CF030106,16BF025606, 16CF016174, 16CF015212, 16CF019546, 16CF026071, 16CF030107,16BF025607, 16CF016175, 16CFOI5213, 16CF019547, 16CF026072, 16CF030108,16BF025608, 16CF016176, 16CF015214, 16CF019548, I6CF026073, 16CF030109,16BF025609, 16CF016177, 16CF015215, 16CF019549, l6CF026074, 16CF030110,16BF025610, 16CF016178, 16CF015216, l6CF019550, l6CF026075, 16CF0301ll,16BF025611, 16CF016179, 16CF018612, 16CF019551, 16CF026076, 16CF030112,16BF025612, 16CF016180, 16CF018613, 16CF019552, l6CF026077, 16CF030113,16BF025613, 16CF016181, 16CF018614, 16CF019553, 16CF026078, 16CF030114,16BF025614, 16CF016182, 16CF018615, 16CF019554, 16CF026079, 16CF030115,16BF025615, 16CF016183, 16CF018616, 16CF019555, 16CF026080, l6CF030116,16BF025616, 16CF016184, 16CF018617, 16CF019556, 16CF026081, 16CF030117,16BF025617, 16CF016185, 16CF018618, 16CF019557, 16CF026082, 16CF030118,16BF025618, 16CF016186, 16CF018619, 16CF019558, 16CF026083, 16CF030119,16BF025619, 16CF016187, 16CFOI8620, 16CF019559, 16CF026084, 16CF030120,16BF025620, 16CF016188, 16CF018621, 16CF019560, 16CF026085, 16CF030121,16BF025621, 16CF016189, 16CF018622, 16CF019561, 16CF026086, 16CF030122,16BF025622, 16CF016190, 16CF018623, 16CF019562, 16CF026087, 16CF030123,16BF025623, 16CF016191, 16CF018624, 16CF019563, 16CF026088, 16CF030124,16BF025624, 16CF016192, 16CF018625, 16CF019564, 16CF026089, 16CF032012,16BF025625, 16CF016193, 16CF018626, 16CF019565, 16CF026090, 16CF032013,16BF025626, 16CF016194, 16CF018627, 16CF019566, 16CF026091, 16CF032014,16BF025627, 16CF016195, 16CF018628, 16CF023329, 16CF026092, 16CF032015,16BF025628, 16CF016196, 16CF018629, 16CF023330, 16CF027673, 16CF032016,16BF025629, 16CF016197, 16CF018630, 16CF023331, 16CF027674, 16CF032017,16BF025630, 16CF016198, 16CF018631, 16CF023332, 16CF027675, 16CF032018,16BF025631, 16CF015181, 16CF018632, 16CF023333, 16CF027676, 16CF032019,16BF025632, 16CF015182, 16CF018633, 16CF023334, 16CF027677, 16CF032020,16BF025633, 16CF015183, 16CF018634, 16CF023335, 16CF027678, 16CF032021,16BF025634, 16CF015184, 16CF018635, 16CF023336, 16CF027679, 16CF032022,16BF025635, 16CF015185, 16CF018636, 16CF023337, 16CF027680, 16CF032023,16BF025636, 16CF015186, 16CF018637, 16CF023338, 16CF027681, 16CF032024,16BF025637, 16CF015187, 16CF018638, 16CF023339, 16CF027682, 16CF032025,16BF025638, 16CF015188, 16CF018639, 16CF023340, 16CF027683, 16CF032026,16BF025639, 16CF015189, 16CFOI8640, 16CF023341, 16CF027684, 16CF032027,16BF025640, 16CF015190, 16CF018641, 16CF023342, 16CF027685, 16CF032028,16BF025641, 16CF015191, 16CF018642, 16CF023343, 16CF027686, 16CF032029,16BF027950, 16CF015192, 16CF018643, 16CF023344, 16CF027687, 16CF032030,16BF027951, 16CF015193, 16CF018644, 16CF023345, 16CF027688, 16CF040048,16BF027952, 16CF015194, 16CF018645, 16CF023346, 16CF030089, 16CF040049,16BF030583, 16CF015195, 16CF018646, 16CF023347, 16CF030090, 16CF040050,16BF030584, 16CF015196, 16CF018647, 16CF023348, 16CF030091, 16CF040051,16BF030585, 16CF015197, 16CF019531, 16CF023349, 16CF030092, 16CF040052,16BF030586, 16CF015198, 16CF019532, 16CF026057, 16CF030093, 16CF040053,16BF030587, 16CF015199, 16CF019533, 16CF026058, 16CF030094, 16CF040054,16BF030588, 16CF015200, 16CF019534, 16CF026059, 16CF030095, 16CF040055,16BF030589, 16CF015201, 16CF019535, 16CF026060, 16CF030096, 16CF040056,16BF030590, 16CF015202, 16CF019536, 16CF026061, 16CF030097, 16CF040057,16BF030591, 16CF015203, 16CF019537, 16CF026062, 16CF030098, 16CF040058,16BF030592, 16CF015204, 16CF019538, 16CF026063, 16CF030099, 16CF040059,16CF040060,16CF040061,16DF017166, 16DF017167, 16DF017910,16DF017911, 16DF040084 16DF040085, 16DF040632,16DF040633, 16DF045327,16DF045328,16CF040062, 16DF017168, 16DF017912, 16DF040086, 16DF040634, 16DF045329,16CF040063, 16DF017169, 16DF017913, 16DF040087, 16DF040635, 16DF045330,16CF040064, 16DF017170, 16DF017914, 16DF040088, 16DF040636, 16DF045331,16CF040065, 16DF017171, 16DF017915, 16DF040089, 16DF040637, 16DF045332,16CF040066, 16DF017172, 16DF017916, 16DF040090, 16DF040638, 16DF045333,16CF040067, 16DF017173, 16DF017917, 16DF040091, 16DF040639, 16DF045334,16CF040068, 16DF017174, 16DF017918, 16DF040092, 16DF040640, 16DF045335,16CF040069, 16DF017175, 16DF017919, 16DF040093, 16DF040641, 16DF045336,16CF040070, 16DF017176, 16DF017920, 16DF040094, 16DF040642, 16DF045337,16CF040071, 16DF017177, 16DF017921, 16DF040095, 16DF040643, 16DF045338,16CF040072, 16DF017178, 16DF017922, 16DF040096, 16DF040644, 16DF045339,16CF040073, 16DF017179, 16DF017923, 16DF040097, 16DF040645, 16DF045340,16CF040074, 16DF017180, 16DF017924, 16DF040098, 16DF040646, 16DF045341,16CF040075, 16DF017181, 16DF017925, 16DF040099, 16DF040647, 16DF045342,16CF040076, 16DF017182, 16DF017926, 16DF040100, 16DF040648, 16DF045343,16CF040077, 16DF017183, 16DF017927, 16DF040101, 16DF040649, 16EF000999,16CF040078, 16DF017184, 16DF017928, 16DF040102, 16DF040650, 16EF001000,16CF040079, 16DF017185, 16DF017929, 16DF040103, 16DF041832, 16EF001001,16CF040080, 16DF017186, 16DF019605, 16DF040104, 16DF041833, 16EF001002,16CF040081, 16DF017187, 16DF019606, 16DF040615, 16DF041834, 16EF001003,16CF040082, 16DF017894, 16DF019607, 16DF040616, 16DF045311, 16EF001004,16CF040083, 16DF017895, 16DF040069, 16DF040617, 16DF045312, 16EF001005,16DF017152, 16DF017896, 16DF040070, 16DF040618, 16DF045313, 16EF001006,16DF017153, 16DF017897, 16DF040071, 16DF040619, 16DF045314, 16EF001007,16DF017154, 16DF017898, 16DF040072, 16DF040620, 16DF045315, 16EF001008,16DF017155, 16DF017899, 16DF040073, 16DF040621, 16DF045316, 16EF001009,16DF017156, 16DF017900, 16DF040074, 16DF040622, 16DF045317, 16EF001010,16DF017157, 16DF017901, 16DF040075, 16DF040623, 16DF045318, 16EF001011,16DF017158, 16DF017902, 16DF040076, 16DF040624, 16DF045319, 16EF001012,16DF017159, 16DF017903, 16DF040077, 16DF040625, 16DF045320, 16EF001013,16DF017160, 16DF017904, 16DF040078, 16DF040626, 16DF045321, 16EF001014,16DF017161, 16DF017905, 16DF040079, 16DF040627, 16DF045322, 16EF001015,16DF017162, 16DF017906, 16DF040080, 16DF040628, 16DF045323, 16EF001016,16DF017163, 16DF017907, 16DF040081, 16DF040629, 16DF045324, 16EF001017,16DF017164, 16DF017908, 16DF040082, 16DF040630, 16DF045325, 16EF001020,16DF017165, 16DF017909, 16DF040083, 16DF040631, 16DF045326, 16EF001021.
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| Z-1130-2022 | Class II | Invacare TDX SP2, Model Nos. TDXSP2 TDXSP2-MCG... | Mar 30, 2022 |
| Z-0445-2022 | Class II | Invacare TDX SP2 with LiNX Gyro Power Wheelchai... | Nov 12, 2021 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.