Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall LifeCare PCA 3

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall LifeCare PCA 3see related information
Date Initiated by FirmMarch 08, 2013
Create DateSeptember 22, 2016
Recall Status1 Terminated 3 on November 07, 2016
Recall NumberZ-2874-2016
Recall Event ID 64230
510(K)NumberK042800 
Product Classification Pump, infusion, pca - Product Code MEA
ProductLifeCare PCA 3, PCA Serial List Number 12384 Allows for clinician administration or self-administration of analgesic medications.
Code Information Serial Number 12921204  12922976  12924008  12925861  12925924  12925998  12928528  12928807  12929016  12929126  12920432  12920820  12920856  12920915  12921404  12921413  12922304  12922976  12925861  12925998  12927215  12929016  12931044  12931141  12931155  12931192  12931244  12931342  12931361  12931413  12931610  12931639  12931649  12931911  12921480  12921487  12923723  12924326  12924350  12924546  12925259  12925447  12926315  12927938  12928075  12928614  12930418  12930709  12930890  12931441  12931760  12931911  12932487  12932717  12920754  12920791  12920897  12921063  12921613  12922062  12923441  12924161  12926859  12927756  12928775  12929346  12929438  12931942  12920112  
Recalling Firm/
Manufacturer		 Hospira Inc.
275 N Field Dr
Lake Forest IL 60045-2579
For Additional Information ContactChris Eustace
224-212-2000
Manufacturer Reason
for Recall		Screw rotation error occurring when the pump detects a mismatch between the number of steps given to the motor driving delivery and the number of steps the motor actually took. When this malfunction occurs, the pump will alarm and infusion stops.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionHospira will contract with Stericycle, Inc. in Indianapolis, IN to send letter and a reply form to Hospira, Inc. Receipt of the letters will be confirmed by UPS tracking. Customers will be requested to return a reply form to Stericycle indicating the number of pumps on hand and that they have received the letter and notified their users. In addition, letters will be sent by email to ECRI, NRAC, Noblis and ISMP for notification of their members and posting on their websites. The letter will also be posted to the Hospira website. Letters will be sent to Hospira customers of record who purchased the devices directly from Hospira. Customers will be directed to notify their consignees if they further distributed the product and confirm they have done so. Telephone attempts will be made to contact customers that do not respond in order to confirm receipt of the letter. Final effectiveness will be done as the devices are upgraded with new plastic motors.
Quantity in Commerce69
DistributionUnited States (Nationwide) Distribution including Puerto Rico and American Virgin Islands.
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 = MEA
-
-