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Terminated

Cook brand Keller-Timmermans Introducer Set, curved with Rutner adapter includes: sheath 18.0 FR, 85 cm long without wire guide; VSSW-18.0-38-85-C-KTI.

FDA Recall Z-1217-04 · Posted 2004-07-27

Recalling FirmCook, Inc.
Recall StatusTerminated
Product CodeMIH
Date Initiated2004-06-10
Date Terminated2004-11-01
Product Quantity25

Reason for Recall

Introducer tubing may contain a vein of unextruded material and carbon black or a strand of tubing material may be displaced from the introducer during use.

Firm Action

The firm issued recall letters to customers on 6/10/04. The recall was extended and URGENT EXTENSION OF PRODUCT RECALL notices were sent out on June 23, 2004.

Root Cause

Other

Distribution Pattern

Nationwide, Canada, Denmark and Japan.

Official Source

View FDA Recall →

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

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