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.
This recall has been terminated (originally issued October 6, 2009).
- Company
- Hospira Inc
- Recall Initiated
- August 11, 2009
- Posted
- October 6, 2009
- Terminated
- November 30, 2010
- Recall Number
- Z-0016-2010
- Quantity
- 204,999 total
- Firm Location
- Morgan Hill, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard.
Distribution
Worldwide Distribution
Lot / Code Info
AC power cords Part Numbers: 826-85559-001, 826-85559-003, 826-85559-008, 826-85559-010, and 826-96057-003.
Root Cause
Component design/selection
Action Taken
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.