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U.S. Department of Health and Human Services

Class 2 Device Recall Hospira Primary Microbore Gemstar Split Set

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  Class 2 Device Recall Hospira Primary Microbore Gemstar Split Set see related information
Date Initiated by Firm March 28, 2011
Date Posted April 19, 2011
Recall Status1 Terminated 3 on May 09, 2012
Recall Number Z-2027-2011
Recall Event ID 58276
510(K)Number K103224  
Product Classification Instrument, surgical, disposable - Product Code KDC
Product Hospira Primary Microbore Gemstar Split Set, Integral PAV, Yellow Striped Tubing, 110 Inch, Non-DEHP; a sterile Rx tubing set for epidural administration of fluids with the Gemstar Pump; Made in Costa Rica; Hospira, Inc., Lake Forest, IL 60045 USA; List No. 13744-28

For epidural administration of fluids with the Gemstar Pump
Code Information List No. 13744-28, lots 930345H, 931425H, 932785H  
Recalling Firm/
Hospira Inc.
275 N Field Dr
Lake Forest IL 60045-2579
For Additional Information Contact Ms. Ileana Quinones
Manufacturer Reason
for Recall
There is a potential for the air filter at the distal end of the set to become detached. This could result in the contamination of the sterile fluid path inside the tubing.
FDA Determined
Cause 2
Action The firm, Hospira, sent an "URGENT DEVICE RECALL" letter dated March 28, 2011 to their customers. The letter described the product, problem and actions to be taken. The customers were instructed to check their inventory and immediately quarantine any affected product; complete and return the Reply Form via fax to 1-866-324-3734, even if you do not have the affected product; inform healthcare professionals in their organization of this recall; if they have distributed the product further, notify their accounts and have them fax the reply form to 1-866-324-3724; return the affected product to Stericycle using labels provided, and call Stericycle at 1-877-877-0481, if they have not received a return label. For medical inquiries, please call Hospira Medical Communications at 1-800-615-0187. Call Hospira Global Product Safety and Complaints at 1-800-441-4100 (8am-5pm CST, M-F) or by e-mail at (ProductComplaintsPP@hospira.com).
Quantity in Commerce 61,150 sets
Distribution Worldwide distribution: USA (nationwide) and countries including: Canada, Korea and Singapore.
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 = KDC and Original Applicant = HOSPIRA, INC.