FDA-Device2013-08-14Class I

List No. 14210-28; PLUM BLOOD SET; 100 mL Burette with Prepierced Injection Site, 170 Micron Filter, Prepierced Port, Non-Vented, 105 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
96 units
Manufactured in
275 N Field Dr, N/A, Lake Forest, IL, United States
Products
List No. 14210-28; PLUM BLOOD SET; 100 mL Burette with Prepierced Injection Site, 170 Micron Filter, Prepierced Port, Non-Vented, 105 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-1854-2013

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