Z-0292-2012

Hospira LifeShield Latex-Free 150 mL Burette Set, with Calibrated Burette and 2 Clave Ports, Convertible Pin...

Name: Z-0292-2012 Hospira LifeShield Latex-Free 150 mL Burette Set, with Calibrated Burette and 2 Clave Ports, Convertible Pin...
Creator: Hospira Inc.
Published: 2011-11-10
License: https://open.fda.gov/license/

Abbott Medical / initiated 2011-11-10 / Terminated / root cause: manufacturing process

FDA source

Hospira Inc. began a recall of Hospira LifeShield Latex-Free 150 mL Burette Set, with Calibrated Burette and 2 Clave Ports, Convertible Pin, 77 inch , Soluset Microdrip with Option-Lok; an... on 2011-11-10. The reason FDA records is "The float valve in the burette sticks to the burette wall and does not open or close properly". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0292-2012
Status: Terminated
Initiated: 2011-11-10
Posted: 2011-11-25
Terminated: 2016-12-15
Recalling firm: Abbott Medical
Product: Hospira LifeShield Latex-Free 150 mL Burette Set, with Calibrated Burette and 2 Clave Ports, Convertible Pin, 77 inch , Soluset Microdrip with Option-Lok; 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 19208-01 Intended use: for the administration of fluids
Product code: FPA Set, Administration, Intravascular
Reason for recall: The float valve in the burette sticks to the burette wall and does not open or close properly.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: The firm, Hospira, sent an "URGENT DEVICE RECALL" letter dated November 10, 2011 to the customers of record via UPS on the same date. The customers were instructed to check their inventory and immediately quarantine any affected product; complete and return Reply Form via fax to 1-866-913-0667 or email to: [email protected]; return affected product to Stericycle using the label provided with this letter; and if they have distributed the product further, notify their accounts that received the product . Please contact Hospira Customer Care at 1-877-946-7747 or your Hospira representative for information regarding product availability.
Quantity in commerce: 12,580 units
Distribution: Worldwide distribution: USA (nationwide) including states of: Alabama, Alaska, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kentucky, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Vermont, Virginia, Washington and Wisconsin, and internationally to Canada
Product codes and lots: list 19208-01, lot number 83-107-5H

Product code FPA

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)