Class 2 Device Recall Hospira Accessory Power Pack

• Date Initiated by Firm: July 02, 2010
• Date Posted: August 17, 2010
• Recall Status: Terminated on July 20, 2011
• Recall Number: Z-2234-2010
• Recall Event ID: 56138
• Product Classification: Infusion Pump - Product Code FRN
• Product: Hospira Accessory Power Pack; a 4 outlet power strip with a custom pole clamp bracket to attach to the IV pole with the infusion pump; Distributed by: Hospira, Inc., 275 N. Field Drive, Lake Forest, IL 60045; part number 39003-04-01, Modo #HSP1700, Model Tripp-Lite PS-415-HG Accessory power pack used for use with medical devices.
• Code Information: part number 39003-04-01, lots 102806, 57001G3, 59034G3, 62002G3, and 64009G3.
• Recalling Firm/ Manufacturer: Hospira Inc.; 375 N Field Dr; Lake Forest IL 60045
• For Additional Information Contact: Ms. Ileana Quinones; 224-212-4892
• Manufacturer Reason for Recall: The Power Pack Accessory is not certified to UL 60601 standard or Subject 1363A for relocatable power taps intended for use with medical equipment. Potential problems could include electrical shock, electrical short or electrical fire.
• FDA Determined Cause: Device Design
• Action: Hospira sent Urgent Device Recall letters dated 7/1/10 to their direct accounts on 7/2/10 via Federal Express 2 day delivery, informing them of the potential for electrical shock, electrical short, or electrical fire, since the power packs were not certified to UL 60601 standard or Subject 1363A of UL standard 1363 for relocatable power taps intended for use with medical equipment. The accounts were instructed to examine their inventory for the affected product and quarantine it immediately, and Stericycle at 1-800-321-7388 to obtain a return kit for returning the affected product. If they distributed the affected product further, they were instructed to sub-recall the product from their sub-accounts. They were also requested to complete the enclosed reply form and return it to Hospira by fax at 1-262-577-6921, indicating the amount of product placed on hold for return, if they further distributed the product and if they notified their retail customers. For medical inquiries, the accounts were directed to contact Hospira Medical Communications at 1-800-615-0187.
• Quantity in Commerce: 1,766 units
• Distribution: Worldwide Distribution -- US and Canada.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.