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Terminated

Tri-State Hospital Supply Corp., Centurion Healthcare Products Premie Packs, 50, sterile, Tri-State Hospital Supply Corp., Howell, MI; code no. LM110. Aspiration tray containing Portex uncuffed pediatric sized tracheal tubes.

FDA Recall Z-0105-2010 · Posted 2009-11-12

Recalling FirmCenturion Medical Products
Recall StatusTerminated
Product CodeBTR
Date Initiated2009-09-22
Date Terminated2010-08-03
Product Quantity650

Reason for Recall

The pediatric tracheal tubes used in these kits were manufactured with an internal diameter smaller than indicated in the label, which could result in an inability to remove secretions and cause partial or complete obstruction of the airway.

Firm Action

The firm's sales representative was notified of the recall on September 22, 2009 via email and the sole customer was notified by letter dated September 23, 2009. All product was removed from the customer account on September 28, 2009 and returned to the recalling firm.

Root Cause

Process control

Distribution Pattern

Illinois.

Official Source

View FDA Recall →

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

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