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U.S. Department of Health and Human Services

Class 2 Device Recall Hospira Accessory Power Pack

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 Class 2 Recall
Hospira Accessory Power Pack
see related information
Date Posted August 17, 2010
Recall Status1 Terminated on July 20, 2011
Recall Number Z-2234-2010
Recall Event ID 56138
Product Classification Pump, Infusion - 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, Illinois 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 2
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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