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U.S. Department of Health and Human Services

Class 2 Device Recall LifeShield LatexFree HEMA YType Blood Set IV Administration Set

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 Class 2 Recall
LifeShield LatexFree HEMA YType Blood Set IV Administration Set
see related information
Date Posted March 06, 2014
Recall Status1 Open
Recall Number Z-1126-2014
Recall Event ID 67038
Premarket Notification
510(K) Number
K101677 
Product Classification Set, Administration, Intravascular - Product Code FPA
Product *** 1) List number 126970465 labeled in part: 12697-65 LifeShield LATEX-FREE HEMA; Y-TYPE BLOOD SET, Nonvented, 88 Inch with 210 Micron Filter Pump, Prepierced Injection Site and Secure Lock; Made in Costa Rica; Product Inquiries should be directed to Hospira, Inc., Lake Forest, IL 60045 USA; *** 2) List Number 127200465 labeled in part: 12720-65 LifeShield LATEX-FREE HEMA; BLOOD SET, Nonvented, 81 Inch with 170 Micron Filter, Pump, Prepierced Injection Site and Secure Lock; Made in Costa Rica; Product Inquiries should be directed to Hospira, Inc., Lake Forest, IL 60045 USA; *** 3) List Number 046419701 labeled in part: Hospira VENISYSTEMS Blood Bottle Pump Set with CAIR Clamp Hospira infusion blood sets are intended for the delivery of fluids, including but not limited to, blood and blood products, from a container to a patient's vascular system.
Code Information *** 1) List number 126970465; Lot Numbers: 281145H, 180015H, 040115H, 8804085H, 782245H, 680585H; *** 2) List Number 127200465; Lot Numbers: 161475H, 153405H, 031595H; *** 3) List Number 046419701: Lot Numbers: 040945G, 131335G
Recalling Firm/
Manufacturer
Hospira Inc.
275 N Field Dr
Lake Forest, Illinois 60045-2579
For Additional Information Contact Hospira Global Complaint Management
800-441-4100
Manufacturer Reason
for Recall
Several lots of the LifeShield Latex-Free HEMA Y-Type Blood Set IV Administration Set were assembled incorrectly.
FDA Determined
Cause 2
DESIGN: Process Design
Action The firm, Hospira, sent "URGENT MEDICAL DEVICE CORRECTION" letters dated October 25, 2013 to all direct accounts/customers.The letter described the product, problem and actions to be taken. The letters instructed customers to: discontinue use of the recalled product lots; search storage areas, supply carts, and other patient care areas for affected lots and to remove any discovered recalled products; quarantine all recalled products; complete and return the attached RESPONSE REQUIRED form via fax at 1-888-356-6430 or e-mail to: Hospira6107@stericycle.com; return affected products using the labels supplied with the letter; if you have not received a return label or reply form or require additional assistance; and, if the recalled products were further distributed, to forward the recall information to them and have them call Stericycle at 866-229-7775 (Monday - Friday, 8:00 AM - 5:00 PM EST) to receive a reply form. The letter further instructs customers to ensure that the facility's protocol(s) for administering fluids and blood products are followed and to report any backflow, inability or difficulty priming, or no flow issues to Hospira at 800-441-4100 (Monday - Friday, 8:00 AM - 5:00 PM CST) or via e-mail at ProductComplaintsPP@hospira.com. For further inquiries, please contact Hospira using the information provided: Reports of adverse events or product complaints can be made by contacting Hospira Global Complaint Management at 800-441-4100 (Monday - Friday, 8:00 AM - 5:00 PM CST) of via e-mail at ProductComplaintsPP@hospira.com. General medical inquiries can be made by contacting Hospira Medical Communications at 800-615-0187 (24 hours a day, 7 days a week) or via e-mail at medcom@hospira.com. This information was also posted to Hospira's Internet website.
Quantity in Commerce *** 1) List Number 126970465: 21,860 units; *** 2) List Number 127200465 : 20,256 units; *** 3) List Number 046419701 : 26,900 units
Distribution Worldwide Distribution: US (nationwide) including states of: AL, AR, AZ, CA, FL, GA, IL, IN, KS, KY, LA, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OR, PA, TN, TX, VA, WI, WV and Puerto Rico; and countries of Canada, Espana, France, Ireland, and Slovenia.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FPA and Original Applicant = HOSPIRA, INC.
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