RecallDepth

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

This recall has been terminated (originally issued June 17, 2003).

Company
Abbott Laboratories Hpd/Add
Recall Initiated
May 13, 2003
Posted
June 17, 2003
Terminated
November 20, 2003
Recall Number
Z-0934-03
Quantity
60 units
Firm Location
Abbott Park, IL
Official Source
View on FDA website ↗

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

Distribution

New Orleans, LA

Lot / Code Info

List number 15252-04-02, lot 940285H

Root Cause

Other

Action Taken

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.

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