Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2234-2010

Hospira Accessory Power Pack; a 4 outlet power strip with a custom pole clamp bracket to attach to the IV...

Abbott Medical / initiated 2010-07-02 / Terminated / root cause: design

Hospira Inc. began a recall of 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... on . The reason FDA records is "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-2234-2010
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Abbott Medical
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.
Product code
FRN Pump, Infusion
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.
Root cause tag
design
FDA root 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.
Product codes and lots
part number 39003-04-01, lots 102806, 57001G3, 59034G3, 62002G3, and 64009G3.