RecallDepth

Pentalumen TD Thermodilution Catheter, Sterile

Company
Abbott Laboratories Hpd/Add/Gprd
Recall Initiated
November 19, 2003
Posted
July 20, 2004
Terminated
April 14, 2004
Recall Number
Z-0305-04
Quantity
495 units
Firm Location
Abbott Park, IL

Reason for Recall

Thermodilution catheters have a potential for ruptured lumens within the catheter.

Distribution

AR,AZ, CA, FL, LA, MA, NC, OR, PA, TN, TX, UT, VA, WA. VA facilities in AR,AZ,FL and NC. No military or foreign distribution.

Lot / Code Info

List No. 41233-01, Lot 04-187-SN

Root Cause

Other

Action Taken

Consignees were notified by letter on 11/19/2003.

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