Recall Z-1853-2013
Hospira Inc. · initiated April 1, 2013
Class I – dangerous or defective products that could cause serious health problems or death
Product
List No. 14207-28; BLOOD SET; 200 Micron Filter, 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
Codes / lots: List Number: 14207-28; Lot Number: 962295H
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.
FDA-determined cause: Device Design
Action taken
Hospira sent an Important Safety Information letter dated April 1, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to exercise EXTREME CAUTION when using Hospira blood bags and to make sure that all instructions for use are included with the blood bag and their facility's protocol for spiking blood bags are completely followed in order to minimize the possibility of puncturing the outer wall of the blood bag. Customers with issues were instructed to call Hospira at 1-800-441-4100 or email ProductComplaintsPP@hospira.com. Customers were asked to complete the attached replay formand return it to the fax number on the form. If customers distributed the product further they were instructed to notify their accounts that received the affected product and ask them to contact Stericycle at 1-866-608-3936 to receive a reply form. Customers with questions were instructed to contact Hospira at 1-800-441-4100. For questions regarding this recall call 224-212-2000.
Details
- Recall number
- Z-1853-2013
- Initiated
- April 1, 2013
- Posted by FDA
- August 5, 2013
- Terminated
- May 24, 2017
- Product code
- BRZ – Set, Blood Transfusion
- Quantity
- 240 units
- Distribution
- Worldwide Distribution - USA (nationwide) and Puerto Rico and Internationally to Costa Rica.
- Recalling firm
- Hospira Inc., Lake Forest, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1850-2013 Class I | List No. 14200-28; SECONDARY BLOOD SET; 200 Micron Filter, 36 Inch, Non-DEHP; For Blood…It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture… | 04/01/2013Terminated |
| Z-1851-2013 Class I | List No. 14203-28; BLOOD SET; 200 Micron Filter, 80 Inch, Non-DEHP; For Blood Product…It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture… | 04/01/2013Terminated |
| Z-1852-2013 Class I | List No. 14206-28; Y-TYPE BLOOD SET; 200 Micron Filter, Cylinder Pump, Convertible Pin…It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture… | 04/01/2013Terminated |
| Z-1854-2013 Class I | List No. 14210-28; PLUM BLOOD SET; 100 mL Burette with Prepierced Injection Site, 170…It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture… | 04/01/2013Terminated |
| Z-1855-2013 Class I | List No. 14211-28; PLUM BLOOD SET; Prepierced Port, 200 Micron Filter, 110 Inch…It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture… | 04/01/2013Terminated |
| Z-1856-2013 Class I | List No. 14212-28; PLUM Y-TYPE BLOOD SET; 200 Micron Filter, CLAVE Port, Non-Vented, 110…It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture… | 04/01/2013Terminated |
| Z-1857-2013 Class I | List No. 14217-28; Y-TYPE BLOOD SET; 200 Micron Filter, Prepierced Y-Site, Non-Vented…It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture… | 04/01/2013Terminated |
| Z-1858-2013 Class I | List No. 14219-28; Y-TYPE BLOOD SET; 200 Micron Filter, Cylinder Pump, CLAVE Y-Site…It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture… | 04/01/2013Terminated |