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
FDA Recall Z-0292-2012 · Posted 2011-11-25
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Recalling FirmHospira Inc.
Recall StatusTerminated
Product CodeFPA
Date Initiated2011-11-10
Date Terminated2016-12-15
Product Quantity12,580 units
Reason for Recall
The float valve in the burette sticks to the burette wall and does not open or close properly.
Firm 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.
Root Cause
Employee error
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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