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U.S. Department of Health and Human Services

Class 2 Device Recall Plum XLM

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 Class 2 Device Recall Plum XLMsee related information
Date Initiated by FirmAugust 11, 2009
Date PostedOctober 06, 2009
Recall Status1 Terminated 3 on November 30, 2010
Recall NumberZ-0033-2010
Recall Event ID 52866
510(K)NumberK952799 
Product Classification Infusion Pump - Product Code FRN
ProductPlum 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.
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 2
Component design/selection
ActionFirm 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 Commerce204,999 total
DistributionWorldwide Distribution
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = FRN
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