The Recall Desk
HighFDA (Devices)·Z-2075-2012·Announced 2012-08-01

Hospira LifeShield Burette Set Recalled Due to Sticking Float Valve

Hospira is recalling 4,420 LifeShield Latex-Free 100 mL Burette Sets because the float valve may stick to the burette wall and fail to open or close properly.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a functional defect in a medical device used for fluid administration that could lead to improper dosing or administration, representing a risk of harm where injury has not yet been reported.

Plain-English summary

Hospira Inc. is recalling 4,420 sets of Hospira LifeShield Latex-Free 100 mL Burette Sets, list 12722-65, lot number 96-098-5H. These are prescription sterile medical devices used for the administration of fluids. The sets are distributed worldwide, including nationwide in the United States and in Barbados and Canada.

The recall is due to a defect where the float valve in the burette sticks to the burette wall and does not open or close properly. This malfunction could interfere with the intended use of the device for fluid administration.

Healthcare facilities and consumers who have these specific sets should stop using them and contact Hospira Inc. for instructions on return or replacement. The affected product is identified by list 12722-65 and lot number 96-098-5H.

The recalled product

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 p
Manufacturer
Hospira Inc.
Affected units
4,420

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • list 12722-65
  • lot number 96-098-5H

Distribution

Distributed nationwide across the United States.

The notice also names 16 states specifically: