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Terminated

LifeShield Latex-Free Microdrip Soluset 100 mL Burette Plumset Convertible Pin, 121-1/2 Inch with CLAVE and OPTION-LOK Dual Channel Secondary Port, product 19289

FDA Recall Z-0915-03 · Posted 2003-06-05

Recalling FirmAbbott Laboratories HPD/ADD
Recall StatusTerminated
Product CodeFRN
Date Initiated2003-05-13
Date Terminated2003-11-20
Product Quantity5,680 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.

K832755INFUSION PUMP & IV SETS #4000Omni-Glow, Inc. · 1983-11-03

Official Source

View FDA Recall →

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

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