Z-1852-2013Class I

List No. 14206-28; Y-TYPE BLOOD SET; 200 Micron Filter, Cylinder Pump, Convertible Pin and Non-Vented Pin, 80...

Name: Z-1852-2013 List No. 14206-28; Y-TYPE BLOOD SET; 200 Micron Filter, Cylinder Pump, Convertible Pin and Non-Vented Pin, 80...
Creator: Hospira Inc.
Published: 2013-04-01
License: https://open.fda.gov/license/

Abbott Medical / initiated 2013-04-01 / Terminated / root cause: design

FDA source

Hospira Inc. began a recall of List No. 14206-28; Y-TYPE BLOOD SET; 200 Micron Filter, Cylinder Pump, Convertible Pin and Non-Vented Pin, 80 Inch, Non-DEHP; For Blood Product Administration... on 2013-04-01. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1852-2013
Classification: Class I
Status: Terminated
Initiated: 2013-04-01
Posted: 2013-08-05
Terminated: 2017-05-24
Recalling firm: Abbott Medical
Product: List No. 14206-28; Y-TYPE BLOOD SET; 200 Micron Filter, Cylinder Pump, Convertible Pin and Non-Vented Pin, 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
Product code: BRZ Set, Blood Transfusion
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.
Root cause tag: design
FDA root cause: Device Design
Action: 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 [email protected]. 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.
Quantity in commerce: 1,976 units
Distribution: Worldwide Distribution - USA (nationwide) and Puerto Rico and Internationally to Costa Rica.
Product codes and lots: List Number: 14206-28; Lot Numbers: 020695H, 100865H

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1852-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1850-2013	Class I	Terminated	Voluntary: Firm initiated	2013-08-14	2013-08-05
Z-1851-2013	Class I	Terminated	Voluntary: Firm initiated	2013-08-14	2013-08-05
Z-1852-2013	Class I	Terminated	Voluntary: Firm initiated	2013-08-14	2013-08-05
Z-1853-2013	Class I	Terminated	Voluntary: Firm initiated	2013-08-14	2013-08-05
Z-1854-2013	Class I	Terminated	Voluntary: Firm initiated	2013-08-14	2013-08-05
Z-1855-2013	Class I	Terminated	Voluntary: Firm initiated	2013-08-14	2013-08-05
Z-1856-2013	Class I	Terminated	Voluntary: Firm initiated	2013-08-14	2013-08-05
Z-1857-2013	Class I	Terminated	Voluntary: Firm initiated	2013-08-14	2013-08-05
Z-1858-2013	Class I	Terminated	Voluntary: Firm initiated	2013-08-14	2013-08-05

Product code BRZ

K101677Class IIHospira Infusion Blood SetsHospira, Inc. / cleared 2010-08-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)