—#84809

Product

Plum LifeCare 5000 (Plum 1.6) with Dataport, list #s 02507-04-11, 02507-04-51; AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA.

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K911401
Affected lot / code info: AC power cords Part Numbers: 826-85559-001, 826-85559-003, 826-85559-008, 826-85559-010, and 826-96057-003.

Why it was recalled

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

Root cause (FDA determination)

Component design/selection

Action the firm took

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.

Recalling firm

Firm: Hospira Inc
Address: 755 Jarvis Dr, Morgan Hill, California 95037-2810

Distribution

Distribution pattern: Worldwide Distribution

Timeline

Recall initiated: 2009-08-11
Posted by FDA: 2009-10-06
Terminated: 2010-11-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #84809. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.