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U.S. Department of Health and Human Services

Class 2 Device Recall Plum A Infusion Pump, Single Channel

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  Class 2 Device Recall Plum A Infusion Pump, Single Channel see related information
Date Initiated by Firm February 06, 2013
Date Posted September 06, 2016
Recall Status1 Terminated 3 on November 14, 2016
Recall Number Z-2722-2016
Recall Event ID 64261
510(K)Number K081412  
Product Classification Pump, infusion - Product Code FRN
Product Plum A+ Hyperbaric Infusion Pump. List Number 11005. 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 11005. Serial numbers: 16792201,  16792202,  16792205,  16792206,  16792208,  16792209,  16792210,  16792211,  16792213,  16792216,  16792217,  16792219,  16792220,  16792222,  16792223,  16792224,  16792225,  16792226,  16792227,  16792228,  16792230,  16792232,  16792233,  16792234,  16792235,  16792236,  16792238,  16792239,  16792240,  16792241,  16792242,  16792244,  16792245,  16792246,  16792248,  16792249,  16792250,  16792251,  16792252,  16792253,  16792254,  16792255,  16792256,  16792257,  16792258,  16792259,  16792260,  16792261,  16792263,  16792264,  16792265,  16792266,  16792268,  16792269,  16792271,  16792272,  16792273,  18807402,  18807405,  18807406,  18807407,  18807408,  18807409,  18807410,  18807413,  18807414,  18807417,  18807418,  18807420,  18807421,  18807423,  18807427,  18807428,  18807429,  18807430,  18807431,  18807432,  18807433,  18807434,  18807439,  18807443,  18807444,  18807446,  18807449,  18807452,  18807453,  18807455,  18807456,  18807459,  18807463,  18807466,  18807472,  18807474,  18807478,  18807484,  18807485,  18807486,  18807490,  18807491,  18807494,  18807496,  18807499,  18807500,  18807501,  18807506,  18807509,  18807510,  18807511,  18807513,  18807514,  18807518,  18807523,  18807524,  18807529,  18807535,  18807536,  18807539,  18807540,  18807541,  18807542,  18807543,  18807545,  18807546,  18807556,  18807557,  18807568,  18807574,  18807575,  18807576,  18807578,  18807581,  18807584,  18807585,  18807586,  18807588,  18807589,  18807590,  18807591,  18807596,  18807597,  18807598,  18807599,  18807600,  18807601,  18807602,  18807604,  18807605,  18807607,  18807608,  18807609,  18807610,  18807611,  18807612,  18807613,  18807614,  18807617,  18807618,  18807619,  18807620,  18807623,  18807625,  18807626,  18807627,  18807628,  18807630,  18807631,  18807632,  18807633,  18807634,  18807636,  18807637,  18807639,  18807640,  18807695,  18807696,  18807697,  18807698,  18807699,  18807700.  
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 2		 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 and Original Applicant = HOSPIRA, INC.
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