Device product
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
Z-1855-2013
Product summary
- Firm
- Hospira Inc.
- Event
- Event 65689
- Status
- Terminated
- Classification
- Class I
- Quantity
- 288 units
- Official record key
device-enforcement:Z-1855-2013
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: 14211-28; Lot Numbers: 052945H, 211855H
Distribution pattern: Worldwide Distribution - USA (nationwide) and Puerto Rico and Internationally to Costa Rica.
Derived failure modes
-
Unknown
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.