Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0022-2010

Plum A+ Infusion System (veterinary), list #s 60529-04-01, 60529-04-03, 60529-04-05; AC cord manufactured by...

Abbott Medical / initiated 2009-08-11 / Terminated / root cause: design

Hospira Inc began a recall of Plum A+ Infusion System (veterinary), list #s 60529-04-01, 60529-04-03, 60529-04-05; AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps... on . The reason FDA records is "Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-0022-2010
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Abbott Medical
Product
Plum A+ Infusion System (veterinary), list #s 60529-04-01, 60529-04-03, 60529-04-05; AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA.
Product code
FRN Pump, Infusion
Reason for recall
Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard.
Root cause tag
design
FDA 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 in commerce
204,999 total
Distribution
Worldwide Distribution
Product codes and lots
AC power cords Part Numbers: 826-85559-001,  826-85559-003,  826-85559-008,  826-85559-010, and  826-96057-003.