Tri-State Hospital Supply Corp., Centurion Healthcare Products Premie Packs, 50, sterile, Tri-State Hospital Supply Corp
FDA device recall Z-0105-2010 · posted 2009-11-12 · Terminated
Recall details
- Recalling firm
- Centurion Medical Products
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- BTR
- Quantity affected
- 650
- Distribution
- Illinois.
- Date initiated
- 2009-09-22
- Date posted
- 2009-11-12
- Date terminated
- 2010-08-03
- Location
- Howell, MI
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