Skip to content
Recall Observatory FDA recall evidence

Device product

List No. 14212-28; PLUM Y-TYPE BLOOD SET; 200 Micron Filter, CLAVE Port, Non-Vented, 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

Z-1856-2013

April 01, 2013

Class I

Product summary

Firm
Hospira Inc.
Event
Event 65689
Status
Terminated
Classification
Class I
Quantity
692,742 units
Official record key
device-enforcement:Z-1856-2013

Official wording

Reason: 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.

Code information: List Number: 14212-28; Lot Numbers: 030575H, 081425H, 090515H, 100905H, 100915H, 102255H, 102265H, 122515H, 122525H, 143405H, 143415H, 152655H, 152665H, 152675H, 161375H, 161385H, 161395H, 170955H, 172025H, 172035H, 172045H, 241805H, 250845H, 251735H, 251745H, 962235H

Distribution pattern: Worldwide Distribution - USA (nationwide) and Puerto Rico and Internationally to Costa Rica.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.