Hospira Inc.: *** 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.

Recall number

Z-1126-2014

Recalling firm

Hospira Inc.

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.

Status

Terminated

Initiated

2013-10-25

Posted

2014-03-06

Terminated

2016-12-15

Reason

Several lots of the LifeShield Latex-Free HEMA Y-Type Blood Set IV Administration Set were assembled incorrectly.

Root cause

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

*** 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.

Lot, serial or model codes

*** 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

510(k) numbers

["K101677"]

PMA numbers

not on file

Product code

FPA

Firm FEI

3013319212

Firm city

Lake Forest

Firm state

IL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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