FDA Device Recall Z-0033-2010: Hospira Inc

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0033-2010.

Recall Res Number

Z-0033-2010

Recalling Firm / Manufacturer

Hospira Inc

FEI Number

2921482

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2009-08-11

Date Posted

2009-10-06

Date Terminated

2010-11-30

Product Code

FRN

Event Number

52866

Product Quantity

204,999 total

Product Description Plum XLM, list #s 11846-04-03, 11846-04-05, 11846-04-07; AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA.

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

Action Details 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 Pattern Worldwide Distribution

Code Information / Serial Numbers AC power cords Part Numbers: 826-85559-001, 826-85559-003, 826-85559-008, 826-85559-010, and 826-96057-003.

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Medical Device Recall: Z-0033-2010

Recall Parameters & Description

Related Establishments / Registrations

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