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U.S. Department of Health and Human Services

Class 2 Device Recall Minibore Extension Set

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  Class 2 Device Recall Minibore Extension Set see related information
Date Initiated by Firm February 19, 2013
Date Posted January 11, 2017
Recall Status1 Terminated 3 on April 24, 2017
Recall Number Z-1016-2017
Recall Event ID 64220
510(K)Number K941214  
Product Classification Tubing, fluid delivery - Product Code FPK
Product Minibore Extension Set, 59 Inch with Spin Lock Collar, Non-DEHP, Latex-Free
Intended use: For the administration of drugs and solutions to a patient's vascular system through a vascular access device.
Code Information Product List Number: 14699-28;  Lot Number: 17-077-NS
Recalling Firm/
Manufacturer		 Hospira Inc.
275 N Field Dr
Lake Forest IL 60045-2579
For Additional Information Contact Global Complaint Management
800-441-4100
Manufacturer Reason
for Recall		 Hospira, Inc. is voluntarily recalling one lot of list 14699-28, Minibore Extension Set, 59 inch with Spin Lock Collar, Non-DEHP, identified above due to a confirmed customer report of an occlusion of solvent in the male luer lock. This occlusion has the potential to prevent the set from being primed for use and cause a delay in therapy.
FDA Determined
Cause 2		 Process control
Action Hospira sent an Urgent Device Recall letter dated February 19, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please check your inventory and immediately quarantine any affected product. Complete the attached reply form and return it to the fax number or e-mail address on the form, even if you do not have the affected product. Inform healthcare professionals in your organization of this recall. Return affected product to Stericycle using the label provided with this letter. If you have not received a return label or require additional assistance contact Stericycle at 1-888-965-5821 between the hours of Bam to 5pm EST, Monday through Friday. To ensure proper and timely credit, follow the instructions on the return label for returning the product. Please visit http://expertezlabel.com to request additional labels for returning affected product. If you have distributed the product further, notify your accounts that received the product identified above of this recall and ask them to contact Stericycle to receive a reply form and return labels for returning the product. Please contact Hospira Customer Care at 1-877-946-7747, between the hours of 6am to 6pm CST, Monday through Friday, or your Hospira representative regarding replacement product availability. For further questions please call (224) 212-2000.
Quantity in Commerce 48,050 units
Distribution Nationwide 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 = FPK and Original Applicant = ABBOTT MFG., INC.
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