Acclaim Encore Infusion Pump, List # 12569-04-03 (veterinary), 12237 04-15, 12273-04-51, AC cord manufactured by Electri

FDA device recall Z-0012-2010 · posted 2009-10-06 · Terminated

Recall details

Recalling firm

Hospira Inc

Reason for recall

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

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.

Root cause

Component design/selection

Status

Terminated

Product code

FRN

Quantity affected

204,999 total

Distribution

Worldwide Distribution

Date initiated

2009-08-11

Date posted

2009-10-06

Date terminated

2010-11-30

Location

Morgan Hill, CA

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