FDA Medical Device Recalls (openFDA)
Hospira Inc: LifeCare PCA Plus II, list #01950-04-03, 01950-04-05, 01950-04-07, 01950-04-51; AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA.
- Recall number
- Z-0016-2010
- Recalling firm
- Hospira Inc
- Product
- LifeCare PCA Plus II, list #01950-04-03, 01950-04-05, 01950-04-07, 01950-04-51; AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA.
- Status
- Terminated
- Initiated
- 2009-08-11
- Posted
- 2009-10-06
- Terminated
- 2010-11-30
- Reason
- Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard.
- Root cause
- Component design/selection
- Action
- Firm initiated its recall on 08/14/2009. A nationwide press release was issued to AP, and an Urgent: Device Field Correction letter to consignees was sent via UPS. The letter recommended that customers check their infusion pumps and spare parts in their inventory to determine if the specified AC Power Cords are in use at their facility; and, to inspect the affected cords for bent or cracked prongs and bridge connection, burnt plastic, or excessive wear and tear. Also, it was recommended that customers immediately discontinue use of the affected cords exhibiting the described characteristics and contact their local Hospira representative for assistance. The letter stated that customers may continue to use and monitor cords that are not exhibiting the described characteristics until replacement cords are sent to their facility. Hospira will contact customers to schedule replacement. Customers are to complete and return the attached Reply Form. Question should be directed to Hospira Customer Service at 1-800-241-4002.
- Quantity
- 204,999 total
- Distribution
- Worldwide Distribution
- Lot, serial or model codes
- AC power cords Part Numbers: 826-85559-001, 826-85559-003, 826-85559-008, 826-85559-010, and 826-96057-003.
- 510(k) numbers
- ["K912928"]
- PMA numbers
- not on file
- Product code
- FRN
- Firm FEI
- 2921482
- Firm city
- Morgan Hill
- Firm state
- CA
- 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