Z-1857-2013 Class I Terminated
FDA device recall Z-1857-2013 was initiated by Hospira Inc. on Apr 1, 2013 and is designated Class I. 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. The recall status is terminated (terminated May 24, 2017). Affected quantity: 1,104 units.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 14, 2013
- Initiation Date
- Apr 1, 2013
- Termination Date
- May 24, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,104 units
Product Description
List No. 14217-28; Y-TYPE BLOOD SET; 200 Micron Filter, Prepierced Y-Site, Non-Vented, 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.
Distribution Pattern
Worldwide Distribution - USA (nationwide) and Puerto Rico and Internationally to Costa Rica.
Code Information
List Number: 14217-28; Lot Number: 962255H
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1857-2013
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026