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Terminated

Pentalumen TD Thermodilution Catheter, Sterile

FDA Recall Z-0305-04 · Posted 2004-07-20

Recalling FirmAbbott Laboratories HPD/ADD/GPRD
Recall StatusTerminated
Product CodeDYG
Date Initiated2003-11-19
Date Terminated2004-04-14
Product Quantity495 units

Reason for Recall

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

Firm Action

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

Root Cause

Other

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K832957FLOW-DIRECTED HEPARIN COATED THERMODILSorensen Research · 1983-09-29K812800FLOW-DIRECTED THERMODILUTION CATHETERSorensen Research · 1981-10-20

Official Source

View FDA Recall →

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

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