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Terminated

T-U-R Y-Set Non-Vented Set for Transurethral Resection Procedures For Use with Flexible Irrigation Container System, 84 inch (213 cm) Nominal Length, No. 15252-02; Made in Costa Rica, Abbott Laboratories, North Chicago, IL 60064

FDA Recall Z-0934-03 · Posted 2003-06-17

Recalling FirmAbbott Laboratories HPD/ADD
Recall StatusTerminated
Product CodeFPA
Date Initiated2003-05-13
Date Terminated2003-11-20
Product Quantity60 units

Reason for Recall

The irrigation set was mislabeled with the wrong delivery rate of 8 drops/mL when it actually has a delivery rate of 11 drops/mL

Firm Action

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

Root Cause

Other

Distribution Pattern

New Orleans, LA

Official Source

View FDA Recall →

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

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