Device Recall LifeShield Primary I.V. Pump Set

  • Model / Serial
    Lot numbers: 520665H, 530685H, 530695H, 530705H, 532335H, 532345H, 532355H, 542145H, 550095H, 560635H, 560645H, 560655H, 570545H, 570555H, 571005H, 571445H, 580515H, 580525H, 600335H, 610775H, 610995H, 620755H, 620765H, and 620775H.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- U.S., Puerto Rico, Dominican Republic, Bahamas, Virgin Islands, Argentina, Australia, Bahrain, Belgium, Canada, China, Denmark, Ecuador, EI Salvador, Finland, France, Germany, Greece, Guatemala, Hong Kong, Ireland, Italy, Jordan, Kuwait, Lebanon, Libya, Mexico, Netherlands, New Zealand, Nicaragua, Norway, Oman, Panama, Peru, Philippines, Poland, Portugal, San Marino, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Uruguay, and United Arab Emirates.
  • Product Description
    Lifeshield, latex-free Primary I.V. Pump set with Distal Microbore Patient Line and Pressure-Activated Anti-Siphon Valve, convertible pin, 109 inch with CLAVE and OPTION-LOK for use OMNI-FLOW Medication Management System, 15 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL USA. Made in Costa Rica, list 12162-01.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Hospira Inc., 375 N Field Dr, Lake Forest IL 60045-2513
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

5 devices with a similar name

Learn more about the data here

  • Model / Serial
    Lot numbers: 561545H and 570995H.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- U.S., Puerto Rico, Dominican Republic, Bahamas, Virgin Islands, Argentina, Australia, Bahrain, Belgium, Canada, China, Denmark, Ecuador, EI Salvador, Finland, France, Germany, Greece, Guatemala, Hong Kong, Ireland, Italy, Jordan, Kuwait, Lebanon, Libya, Mexico, Netherlands, New Zealand, Nicaragua, Norway, Oman, Panama, Peru, Philippines, Poland, Portugal, San Marino, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Uruguay, and United Arab Emirates.
  • Product Description
    Lifeshield, latex-free, Primary I.V. Pump Set with distal microbore patient line and gravity flow prevention valve, convertible pin, 110 inch with orange polyethylene-lined/light resistant tubing and OPTION-LOK for use with OMNI-FLOW infusion system, 15 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL USA. Made in Costa Rica, list 12161-01.
  • Manufacturer
  • Model / Serial
    Lot numbers: 520655H, 530665H, 560565H, 591215H, 591285H, 591735H, and 591745H.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- U.S., Puerto Rico, Dominican Republic, Bahamas, Virgin Islands, Argentina, Australia, Bahrain, Belgium, Canada, China, Denmark, Ecuador, EI Salvador, Finland, France, Germany, Greece, Guatemala, Hong Kong, Ireland, Italy, Jordan, Kuwait, Lebanon, Libya, Mexico, Netherlands, New Zealand, Nicaragua, Norway, Oman, Panama, Peru, Philippines, Poland, Portugal, San Marino, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Uruguay, and United Arab Emirates.
  • Product Description
    Lifeshield, latex-free, Primary I.V. Pump Set with Distal Microbore Patient Line, convertible pin, 110 inch with inline cassette, collection bag, pre-pierced injection site and OPTION-LOK for use with OMNI-FLOW medication management system, 15 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL USA. Made in Costa Rica, list 1169-02.
  • Manufacturer
  • Model / Serial
    Lot numbers: 521765H, 542125H, 560585H, 560595H, 581315H, 600325H, 611595H, and 6213965H.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- U.S., Puerto Rico, Dominican Republic, Bahamas, Virgin Islands, Argentina, Australia, Bahrain, Belgium, Canada, China, Denmark, Ecuador, EI Salvador, Finland, France, Germany, Greece, Guatemala, Hong Kong, Ireland, Italy, Jordan, Kuwait, Lebanon, Libya, Mexico, Netherlands, New Zealand, Nicaragua, Norway, Oman, Panama, Peru, Philippines, Poland, Portugal, San Marino, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Uruguay, and United Arab Emirates.
  • Product Description
    Lifeshield, latex-free, Primary I.V. Pump Set with Distal Microbore Patient Line and Gravity Flow Prevention Valve, convertible pin, 110 inch with pre-pierced injection site and OPTION-LOK for use with OMNI-FLOW medication management system, 15 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL USA. Made in Costa Rica, list 12160-01.
  • Manufacturer
  • Model / Serial
    Lot number: 610735H.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- U.S., Puerto Rico, Dominican Republic, Bahamas, Virgin Islands, Argentina, Australia, Bahrain, Belgium, Canada, China, Denmark, Ecuador, EI Salvador, Finland, France, Germany, Greece, Guatemala, Hong Kong, Ireland, Italy, Jordan, Kuwait, Lebanon, Libya, Mexico, Netherlands, New Zealand, Nicaragua, Norway, Oman, Panama, Peru, Philippines, Poland, Portugal, San Marino, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Uruguay, and United Arab Emirates.
  • Product Description
    Lifeshield, latex-free, Primary I.V. Pump Set with Distal Microbore Patient Line, convertible pin, 110 inch with CLAVE and OPTION-LOK for use with OMNI-FLOW medication management system, 15 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL USA. Made in Costa Rica, list 12383-01.
  • Manufacturer
  • Model / Serial
    Lot numbers: 521785H, 532265H, 532275H, 542135H, 581535H, 590725H, 611245H, 620135H, and 630715H.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- U.S., Puerto Rico, Dominican Republic, Bahamas, Virgin Islands, Argentina, Australia, Bahrain, Belgium, Canada, China, Denmark, Ecuador, EI Salvador, Finland, France, Germany, Greece, Guatemala, Hong Kong, Ireland, Italy, Jordan, Kuwait, Lebanon, Libya, Mexico, Netherlands, New Zealand, Nicaragua, Norway, Oman, Panama, Peru, Philippines, Poland, Portugal, San Marino, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Uruguay, and United Arab Emirates.
  • Product Description
    Lifeshield, latex-free Primary I.V. Pump Set with Distal Microbore Patient Line, Convertible Pin, 72 Inch with 2 Pressure-Activated Anti-Siphon Valve, CLAVE and OPTION-LOK for use OMNI-FLOW, a sterile Rx single use device, Hospira Inc, Lake Forest, IL USA. Made in Costa Rica, list 12566-01.
  • Manufacturer