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Terminated

*** 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.

FDA Recall Z-1126-2014 · Posted 2014-03-06

Recalling FirmHospira Inc.
Recall StatusTerminated
Product CodeFPA
Date Initiated2013-10-25
Date Terminated2016-12-15
Product Quantity*** 1) List Number 126970465: 21,860 units; *** 2) List Number 127200465 : 20,256 units; *** 3) List Number 046419701 : 26,900 units

Reason for Recall

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

Firm 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: [email protected]; 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 [email protected]. 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 [email protected]. 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 [email protected]. This information was also posted to Hospira's Internet website.

Root Cause

Process design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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