RecallDepth

LifeShield Latex-Free 150 mL Burette Set, Nonvented, 117 Inch with Prepierced Injection Site, Backcheck Valve, 2 CLAVE Ports and Removable 4-Way High Flow Stopcock Microdrip Soluset; Product 19292; Made in Costa Rica, Abbott Laboratories, North Chicago, IL 60064

This recall has been terminated (originally issued June 5, 2003).

Company
Abbott Laboratories Hpd/Add
Recall Initiated
May 13, 2003
Posted
June 5, 2003
Terminated
November 20, 2003
Recall Number
Z-0914-03
Quantity
7,160 units
Firm Location
Abbott Park, IL
Official Source
View on FDA website ↗

Reason for Recall

IV Burette administration sets are mislabeled as having pre-pierced injection sites, when the injection sites are not pre-pierced.

Distribution

Nationwide. California, Colorado, Connecticut, Georgia, Illinois, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Michigan, Minnesota, Montana, New Hampshire, New Jersey, New York, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Washington and Wisconsin.

Lot / Code Info

Product number 19292-04-01, lots 961815H and 921675H

Root Cause

Other

Action Taken

Recall letter dated 5/12/03 sent to the accounts on 5/13/03, informing them of the labeling discrepancy and requesting the return of any inventory of the affected lots to Abbott for credit.

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