FDA Medical Device Recalls (openFDA)
Hospira Inc.: 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.
- Recall number
- Z-2234-2010
- Recalling firm
- Hospira Inc.
- 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.
- Status
- Terminated
- Initiated
- 2010-07-02
- Posted
- 2010-08-17
- Terminated
- 2011-07-20
- Reason
- 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
- 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
- 1,766 units
- Distribution
- Worldwide Distribution -- US and Canada.
- Lot, serial or model codes
- part number 39003-04-01, lots 102806, 57001G3, 59034G3, 62002G3, and 64009G3.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FRN
- Firm FEI
- 3004591926
- Firm city
- Lake Forest
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28