Z-2075-2012Class II

Hospira LifeShield Latex-Free 100 mL Burette Set, Convertible Pin, 77 inch with 2 Prepierced Injection Sites...

Name: Z-2075-2012 Hospira LifeShield Latex-Free 100 mL Burette Set, Convertible Pin, 77 inch with 2 Prepierced Injection Sites...
Creator: Hospira Inc.
Published: 2012-07-13
License: https://open.fda.gov/license/

Abbott Medical / initiated 2012-07-13 / Terminated / root cause: manufacturing process

FDA source

Hospira Inc. began a recall of Hospira LifeShield Latex-Free 100 mL Burette Set, Convertible Pin, 77 inch with 2 Prepierced Injection Sites and Option-Lok Microdrip Soluset with Calibrated... on 2012-07-13. FDA classified it as Class II and gives the reason as "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-2075-2012
Classification: Class II
Status: Terminated
Initiated: 2012-07-13
Posted: 2012-07-25
Terminated: 2016-11-28
Recalling firm: Abbott Medical
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.
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 July 13, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The customers were instructed to check their inventory and immediately quarantine any affected product; complete and return Reply Form via fax to 1-877-722-7019 or e-mail to: [email protected]; return affected product to Stericycle using the label provided with the 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: 4,420 sets
Distribution: Worldwide Distribution-USA (nationwide) including the states of California, Colorado, Connecticut, Florida, Illinois, Kentucky, Maryland, Massachusetts, Minnesota, Oklahoma, Texas, Utah, Virginia, Washington, West Virginia and Wyoming, and the countries of Barbados and Canada.
Product codes and lots: list 12722-65, lot number 96-098-5H

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2075-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2075-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-01	2012-07-25

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)