Class 2 Device Recall Plum XL 3

• Date Initiated by Firm: August 11, 2009
• Date Posted: October 06, 2009
• Recall Status: Terminated on November 30, 2010
• Recall Number: Z-0031-2010
• Recall Event ID: 52866
• 510(K)Number: K010924
• Product Classification: Infusion Pump - Product Code FRN
• Product: Plum XL 3, list #s 11781-04-01, 11781-04-03, 11781-04-05; AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA.
• Code Information: AC power cords Part Numbers: 826-85559-001, 826-85559-003, 826-85559-008, 826-85559-010, and 826-96057-003.
• Recalling Firm/ Manufacturer: Hospira Inc; 755 Jarvis Dr; Morgan Hill CA 95037-2810
• For Additional Information Contact: 408-782-3200
• Manufacturer Reason for Recall: Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard.
• FDA Determined 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FRN