—#92726

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.

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
Affected lot / code info: part number 39003-04-01, lots 102806, 57001G3, 59034G3, 62002G3, and 64009G3.

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Hospira Inc.
Address: 375 N Field Dr, Lake Forest, Illinois 60045

Distribution

Distribution pattern: Worldwide Distribution -- US and Canada.

Timeline

Recall initiated: 2010-07-02
Posted by FDA: 2010-08-17
Terminated: 2011-07-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #92726. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.