Electri-Cord Manufacturing Corporation (312 E. Main St., Westfield, PA 16950) AC power cords used with Ranger Irrigation
FDA device recall Z-0897-2010 · posted 2010-03-01 · Terminated
Recall details
- Recalling firm
- Arizant Inc
- Reason for recall
- 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
- Action taken
- An "Urgent Medical Device Power Cord Recall" letter dated December 17, 2009 was sent to customers. The letter was addressed to Recall Coordinator/Biomed Dept. The letter described the affected product, problem, hazard involved, and action to be taken by customer. The customers are being ask to inspect their temperature management units (as described in FDA's recommendation dated October 19, 2009) and contact the firm with the results of their inspection and provide a contact name via website www.arizant.com/powercords or phone (877) 947-1487. Replacement cords and instructions will be provided to customers based on priority listed in the letter and availability of replacement cords. If the customer does not have the means to make the changes, alternate means will be taken (i.e., an Arizant employee or outside service organizations may be brought in to do the replacements). If you have any questions, please contact the Aziant at (877) 47-1487.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- DWJ
- Quantity affected
- Total distributed for all devices: 84,537 US, 7,380 OUS.
- Distribution
- Worldwide Distribution: USA and ARGENTINA, THE BAHAMAS, CANADA, COLOMBIA, COSTA RICA, CUBA, DOMINICAN REPUBLIC, ECUADOR, GERMANY, GUAM, JAPAN, LEBANON, MEXICO, NICARAGUA, PANAMA, PUERTO RICO, QATAR, S
- Date initiated
- 2009-12-17
- Date posted
- 2010-03-01
- Date terminated
- 2012-04-19
- Location
- Eden Prairie, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BAIR PAWS TEMPERATURE MANAGEMENT SYSTEM MODEL 850 (K060865) | Arizant Healthcare, Inc. | 2006-04-24 |
| MODIFICATION TO:BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEMS (K053645) | Arizant Healthcare, Inc. | 2006-03-09 |