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Terminated

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.

FDA Recall Z-0898-2010 · Posted 2010-03-01

Recalling FirmArizant Inc
Recall StatusTerminated
Product CodeDWJ
Date Initiated2009-12-17
Date Terminated2012-04-19
Product QuantityTotal distributed for all devices: 84,537 US, 7,380 OUS.

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

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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