PlainRecalls
FDA Devices Critical Class I Terminated

List No. 14203-28; BLOOD SET; 200 Micron Filter, 80 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

Reported: August 14, 2013 Initiated: April 1, 2013 #Z-1851-2013

Product Description

List No. 14203-28; BLOOD SET; 200 Micron Filter, 80 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

Reason for Recall

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.

Details

Recalling Firm
Hospira Inc.
Units Affected
1,152 units
Distribution
Worldwide Distribution - USA (nationwide) and Puerto Rico and Internationally to Costa Rica.
Location
Lake Forest, IL

Frequently Asked Questions

What product was recalled?
List No. 14203-28; BLOOD SET; 200 Micron Filter, 80 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. Recalled by Hospira Inc.. Units affected: 1,152 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on August 14, 2013. Severity: Critical. Recall number: Z-1851-2013.