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Terminated

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

FDA Recall Z-0914-03 · Posted 2003-06-05

Recalling FirmAbbott Laboratories HPD/ADD
Recall StatusTerminated
Product CodeFPA
Date Initiated2003-05-13
Date Terminated2003-11-20
Product Quantity7,160 units

Reason for Recall

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

Firm Action

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.

Root Cause

Other

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K991932INTRAVASCULAR ADMINISTRATION SETThe Kipp Group · 1999-08-20K915571CLAVE CONNECTORIcu Medical, Inc. · 1992-09-21K791930IV EXTENSION SET SLAbbott Laboratories · 1979-10-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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