Class 2 Device Recall Plum A Infusion Pump, Single Channel

• Date Initiated by Firm: February 06, 2013
• Date Posted: September 06, 2016
• Recall Status: Terminated on November 14, 2016
• Recall Number: Z-2729-2016
• Recall Event ID: 64261
• 510(K)Number: K081412
• Product Classification: Pump, infusion - Product Code FRN
• Product: Plum A+3 Infusion Pump. List Number 12618. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self-contained, microprocessor based infusion devices.
• Code Information: list number 12618. serial numbers: 14040001, 14040002, 14040003, 14040004, 14040005, 14040006, 14040008, 14040009, 14040010, 14040011, 14040012, 14040014, 14040015, 14040016, 14040017, 14040018, 14040019, 14040020, 14040021, 14040022, 14040023, 14040024, 14040025, 14040026, 14040027, 14040027, 14040027, 14040028, 14040028, 14040028, 14040029, 14040030, 14040031, 14040033, 14040034, 14040034, 14040034, 14040035, 14040036, 14040037, 14040038, 14040039, 14040040, 14040041, 14040042, 14040043, 14040044, 14040045, 14040047, 14040048, 14040049, 14040050, 14040051, 14040052, 14040053, 14040054, 14040056, 14040059, 14040061, 14040062, 14040063, 14040064, 14040065, 14040066, 14040067, 14040068, 14040069, 14040070, 14040071, 14040072, 14040073, 14040074, 14040075, 14040076, 14040077, 14040078, 14040079, 14040080, 14040081, 14040082, 14040083, 14040084, 14040085, 14040086, 14040087, 14040088, 14040089, 14040090, 14040091, 14040092, 14040093, 14040094, 14040095, 14040096, 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• Recalling Firm/ Manufacturer: Hospira Inc.; 275 N Field Dr; Lake Forest IL 60045-2579
• For Additional Information Contact: Chris Eustace; 224-212-2000
• Manufacturer Reason for Recall: The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Hospira sent an Urgent Device Field Correction letter, dated February 6, 2013, to customers. Customers were requested to return a reply form to Stericycle indicating that they have received the letter, and notified their users and/or customers. The customers were asked to supply the number of Plum A+ infusers at their facility. Product will be corrected by Hospira in the field.
• Quantity in Commerce: 357,778 total
• Distribution: United States nationwide distribution including PR, and USVI. Costa Rica, Turks and Caicos, and Dominican Republic.
• 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