FDA-Device2013-08-14Class I
List No. 14211-28; PLUM BLOOD SET; Prepierced Port, 200 Micron Filter, 110 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA Hospira Blood sets are designed for Blood Product Administration
Hospira Inc.
Hazard
It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag.
Sold states
Worldwide Distribution - USA (nationwide) and Puerto Rico and Internationally to Costa Rica.
Affected count
288 units
Manufactured in
275 N Field Dr, N/A, Lake Forest, IL, United States
Products
List No. 14211-28; PLUM BLOOD SET; Prepierced Port, 200 Micron Filter, 110 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA Hospira Blood sets are designed for Blood Product Administration
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1855-2013Don't want to check this manually?
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