Arizant Healthcare, Inc.
Eden Prairie, MN, US
Arizant Healthcare, Inc. appears in FDA device records in Eden Prairie, MN. FDA records list 6 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 7 recalls for this company.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Arizant Healthcare, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Arizant Increcall
510(k) clearance history
FDA records hold 6 510(k) clearances for Arizant Healthcare, Inc. between 2004 and 2012. The busiest year on record is 2006, with 3. The most recent is 2012, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2004 | 1 |
| 2006 | 3 |
| 2008 | 1 |
| 2012 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K120412 | 3M SPOTON TEMPERATURE MONITORING SYSTEM | FLL | Substantially Equivalent | |
| K082217 | RANGER RAPID FLOW BLOOD/FLUID WARMING SYSTEM | LGZ | Substantially Equivalent | |
| K060939 | RANGER IRRIGATION FLUID WARMING SYSTEM | LGZ | Substantially Equivalent | |
| K060865 | BAIR PAWS TEMPERATURE MANAGEMENT SYSTEM MODEL 850 | DWJ | Substantially Equivalent | |
| K053645 | MODIFICATION TO:BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEMS | DWJ | Substantially Equivalent | |
| K041686 | BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM | DWJ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0898-2010 | Electri-Cord Manufacturing Corporation(312 E. Main St., Westfield, PA 16950) AC power cords used with Ranger Pressure Infusion Power Pack; Model 90033. To provide power to pressure infusers. | Arizant Healthcare Inc. is initiating a nationwide voluntary recall of 100/110-volt power cords (Arizant part number 502221 Model 90024) attached to its temperature management units and pressure infusion power pack (Bair Paws Temperature Management Units: Models 850 and 875 Bair Hugger Temperature Management Units: Models 500/OR, 505 (Human & Vet.), 750 (Human & Vet) and 775 Ranger Blood/Flui | Terminated | ||
| Z-0897-2010 | Electri-Cord Manufacturing Corporation (312 E. Main St., Westfield, PA 16950) AC power cords used with Ranger Irrigation Fluid Warming Unit; Model 247. Intended to warm irrigation fluids. | Arizant Healthcare Inc. is initiating a nationwide voluntary recall of 100/110-volt power cords (Arizant part number 502221 Model 90024) attached to its temperature management units and pressure infusion power pack (Bair Paws Temperature Management Units: Models 850 and 875 Bair Hugger Temperature Management Units: Models 500/OR, 505 (Human & Vet.), 750 (Human & Vet) and 775 Ranger Blood/Flui | Terminated | ||
| Z-0896-2010 | Electri-Cord Manufacturing Corporation (312 E. Main St., Westfield, PA 16950) AC power cords used with Ranger Blood/Fluid Warming Unit: Model 245. Intended to warm blood, blood products and liquids. | Arizant Healthcare Inc. is initiating a nationwide voluntary recall of 100/110-volt power cords (Arizant part number 502221 Model 90024) attached to its temperature management units and pressure infusion power pack (Bair Paws Temperature Management Units: Models 850 and 875 Bair Hugger Temperature Management Units: Models 500/OR, 505 (Human & Vet.), 750 (Human & Vet) and 775 Ranger Blood/Flui | Terminated | ||
| Z-0895-2010 | Electri-Cord Manufacturing Corporation (312 E. Main St., Westfield, PA 16950) AC power cords used with either Bair Paws Temperature Management Units: Models 850 and 875 Bair Hugger Temperature Management Units: Models 500/OR, 505, 750 and 775 Indicated for hyper- or hypothermic patients or normothermic patients, for whom induced hyper- hypothermia or localized temperature therapy is clinically indicated. In addition, the temperature management systems can be used to provide patient thermal comfort when conditions exist that may cause patients to become too warm or too cold. The temperature management system can be used with adult and pediatric patients. | Arizant Healthcare Inc. is initiating a nationwide voluntary recall of 100/110-volt power cords (Arizant part number 502221 Model 90024) attached to its temperature management units and pressure infusion power pack (Bair Paws Temperature Management Units: Models 850 and 875 Bair Hugger Temperature Management Units: Models 500/OR, 505 (Human & Vet.), 750 (Human & Vet) and 775 Ranger Blood/Flui | Terminated | ||
| Z-1184-2007 | Arizant Healthcare Ranger Standard Flow Blood/Fluid Warming Disposable Sets with injection port and extension set, Part Number 24250. For use with a Ranger warming unit. | Incomplete seal on the product pouch; with the seal incomplete, the sterility of the product inside the pouch cannot be guaranteed. | Terminated | ||
| Z-1183-2007 | Arizant Healthcare Ranger Standard Flow Blood/Fluid Warming Disposable Sets with injection port and extension set, Part Number 24200. For use with a Ranger warming unit. | Incomplete seal on the product pouch; with the seal incomplete, the sterility of the product inside the pouch cannot be guaranteed. | Terminated | ||
| Z-0855-05 | Bair Hugger Temperature Management Blanket, Model 555 Pediatric Full Access Blanket. Use only with a Bair Hugger temperature managemen unit. Not Sterile. Do not use if primary packaging has been previously opened or is damaged. Arizant Healthcare Inc., 10393 West 70th Street, Eden Prairie, MN 55344 USA. | Air channel seals on a limited number of Bair Hugger Model 555 Pediatric underbody blankets could separate when inflated with air from Bair Hugger warming unit. This separation would create a bulging area in the blanket's air channels, which could have a potential to shift the patient's position on the blanket. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain