FDA Recall Terminated

LifeCare PCA 3, list #s 12384-04-01, 12384-04-03, 12384-04-05, 12384-04-07, 12384-04-09, 12384-04-51; AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA.

Recall: Z-0017-2010 · Initiated August 11, 2009

Recall

Recall Number
Z-0017-2010
Event Number
52866
Firm
Hospira Inc
FEI Number
2921482
Product Code
FRN
Status
Terminated
Root Cause
Component design/selection
Initiated
August 11, 2009
Posted
October 6, 2009
Terminated
November 30, 2010
Address
755 Jarvis Dr, Morgan Hill, CA, 95037-2810

Description

LifeCare PCA 3, list #s 12384-04-01, 12384-04-03, 12384-04-05, 12384-04-07, 12384-04-09, 12384-04-51; AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA.

Reason

Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard.

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.

Distribution

Worldwide Distribution

Quantity

204,999 total