iGo2 DC Car Adapter to be used with iGo2 Portable Oxygen Concentrator Systems. Power cord allows the user to operate the device in a vehicl…
Medical Depot Inc. · Potential for DC Power Supply housing to become hot to the touch and deform the plastic housing.
Open FDA's page for this record- Cfres ID
- 213424
- Product res number
- Z-1727-2025
- Event date initiated
- 2025-04-11
- Event date posted
- 2025-05-09
- Recall status
- Open, Classified
- Res event number
- 96700
- Product code
- CAW
- Product description
- iGo2 DC Car Adapter to be used with iGo2 Portable Oxygen Concentrator Systems. Power cord allows the user to operate the device in a vehicle.
- Firm FEI number
- 3002997602
- Recalling firm
- Medical Depot Inc.
- Address 1
- 99 Seaview Blvd Fl 2 99 Seaview Blvd
- Address 2
- Fl 2
- City
- Port Washington
- State
- NY
- Postal code
- 11050-4606
- Additional info contact
- Susan Scott 801-931-1050
- Reason for recall
- Potential for DC Power Supply housing to become hot to the touch and deform the plastic housing.
- Root cause description
- Nonconforming Material/Component
- Product quantity
- 89,532 units
- Code info
DC Cord Code Info: Catalog No. DV6X-619; UDI 885304020585; Cord Revision: Rev E; Lot No. beginning with 2023-01-01 through 2024-12-31. iGo2 Portable Oxygen Concentrator Systems Code Info: Catalog No. 125D, 125D-XB, 125D-BT, 125D-BT-XB, 125D-ARYA-XB; UDI 885304022237, 885304032250, 885304033257, 885304033240, 885304033516; Lot No. D23125001DS to D23A26121DS, D23706001DA to D23B16056DA, F23B06001DS to F25108143DS, F23313001DH to F25109259DH, F24212001DA to F25217150DA.
- Action
An URGENT NOTICE MEDICAL DEVICE RECALL dated 4/11/25 was emailed to consignees. The recall notification instructs consignees on how to identify affected devices in their possession, destroy the affected charger cord, and provides instructions on how to obtain a replacement charger cord through Drive Devilbiss. If product was further distributed, consignees are to contact their customers; Devilbiss has a draft recall notification and recall website available for their consignees who further distributed product. For those units that are rentals, Devilbiss recommends that consignees check devices as they return from rental use. Dan Hinkbein is available to assist consignees who distributed affected devices fulfill recall actions and can be contacted at dan.hinkebein@realtimeresults.net. Consignees with any issues or questions can call Drive Devilbiss Healthcare at 888-770-7017 Monday through Friday from 7:30 AM to 5:00 PM CST. Questions can also be emailed to iGo2-car-cord@realtimeresults.net. The firm has set up a website for this recall event at www.recallrtr.com/iGo2-car-cord.
- Distribution pattern
Worldwide distribution - US Nationwide and the countries of Albania, Austria, Bahrain, Belgium, Bosnia and Herzegovina, Bulgaria, Canada, China, Colombia, Croatia, Cyprus, Czech Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, Iceland, ISRAEL, Italy, JAPAN, Kenya, Kuwait, Latvia, Libya, Lithuania, Malaysia, Maldives, Nepal, Netherlands, Norway, Oman, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Slovak Republic, Slovenia, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad & Tobago, Turkey, Uganda, Ukraine, United Arab Emirates.
- K numbers
- K071397
- Harmonized identifiers (openFDA)
- Device name
- Generator, Oxygen, Portable
- Medical specialty description
- Anesthesiology
- Regulation number
- 868.5440
- Device class
- 2
- K number
- K904087, K251534, K792385, K812693, K813058, K102750, K884084, K072348, K884018, K120566, K251607, K020386, K935370, K851434, K013223, K080082, K811155, K924152, K021685, K954506, K051887, K021082, K091191, K202389, K904639, K851438, K211056, K003472, K861435, K861011, K120785, K071608, K924565, K091716, K081267, K043615, K063454, K941145, K914488, K113317 +249 more
- Registration number
- 2523148, 2085602, 3020476987, 1924066, 3017520736, 1319044, 3009096682, 3004672275, 3014777423, 3017825461, 3005569927, 3027605507, 2032532, 3005587132, 3013000203, 3011191255, 3007740533, 3008507279, 3014661487, 3032013079, 3015772781, 3006534178, 3004964590, 3037045878, 3008910673, 3014810929, 3011767915, 3016859940, 3006240053, 3042507287, 3023272766, 3008841036, 3003803075, 3029227324, 3033814505, 3009327812, 3033526676, 3010317211, 2515872, 3043460907 +46 more
- FEI number
- 2523148, 3020476987, 1924066, 3017520736, 3009096682, 3004672275, 3014777423, 3006277965, 3017825461, 3002806988, 3005569927, 3027605507, 3005587132, 3013000203, 3011191255, 3007740533, 3008507279, 3014661487, 3032013079, 3015772781, 3006534178, 3004964590, 3037045878, 3008910673, 3014810929, 3011767915, 3016859940, 3006240053, 3042507287, 3023272766, 3008841036, 3003803075, 3029227324, 1000115734, 3033814505, 3009327812, 3033526676, 3010317211, 2515872, 3043460907 +46 more