Recall Z-2075-2012— Hospira Inc.

Name: FDA recall Z-2075-2012
Creator: U.S. Food and Drug Administration
Published: 2012-07-13

Class II · Terminated

Class II FDA medical device recall by Hospira Inc., initiated 2012-07-13, terminated 2016-11-28. It names one FDA 510(k) clearance: K101677. Product: Hospira LifeShield Latex-Free 100 mL Burette Set, Convertible Pin, 77 inch with 2 Prepierced Injection Sites and Option-Lok Microdrip Soluset with Calibrated Burette and Precision Drip Chamber; an Rx sterile medical device used to administer fluids; 20 individually wrapped sets per case; Made in Costa Rica, Hospira, Inc., Lake Forest, IL 60045 USA; list 12722-65. Intended use: for the administration of fluids.. Reason: The float valve in the burette sticks to the burette wall and does not open or close properly..

Recalling firm: Hospira Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-07-13
Terminated: 2016-11-28
Firm location: Lake Forest, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K101677 — HOSPIRA INFUSION BLOOD SETSHospira, Inc.·cleared 2010-08-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Hospira LifeShield Latex-Free 100 mL Burette Set, Convertible Pin, 77 inch with 2 Prepierced Injection Sites and Option-Lok Microdrip Soluset with Calibrated Burette and Precision Drip Chamber; an Rx sterile medical device used to administer fluids; 20 individually wrapped sets per case; Made in Costa Rica, Hospira, Inc., Lake Forest, IL 60045 USA; list 12722-65. Intended use: for the administration of fluids.

Reason for recall

The float valve in the burette sticks to the burette wall and does not open or close properly.

Data sourced from openFDA. This site is unofficial and independent of the FDA.