Electri-Cord Manufacturing Corporation (312 E. Main St., Westfield, PA 16950) AC power cords used with Ranger...
Arizant Inc began a recall of 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... on . The reason FDA records is "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-0896-2010
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Arizant Healthcare, Inc.
- Product
- 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.
- Product code
- DWJ System, Thermal Regulating
- 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
- Root cause tag
- manufacturing process
- FDA root cause
- Nonconforming Material/Component
- Action
- 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.
- Quantity in commerce
- 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, SAUDI ARABIA, SOUTH KOREA, SURINAME , TAIWAN, TRINIDAD AND TOBAGO, QATAR.
- Product codes and lots
- Part number 502221 Model 90024
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