FDA Recall
Terminated
Tri-State Hospital Supply Corp., Centurion Healthcare Products, Full Term Meconium Packs, 50, sterile, Tri-State Hospital Supply Corp., Howell, MI; code no. LM115.
Recall: Z-0106-2010
·
Initiated September 22, 2009
Recall
- Recall Number
- Z-0106-2010
- Event Number
- 53550
- Firm
- Centurion Medical Products
- FEI Number
- 1824619
- Product Code
- BTR
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- September 22, 2009
- Posted
- November 12, 2009
- Terminated
- August 3, 2010
- Address
- 301 Catrell Dr, Howell, MI, 48843-1703
Description
Tri-State Hospital Supply Corp., Centurion Healthcare Products, Full Term Meconium Packs, 50, sterile, Tri-State Hospital Supply Corp., Howell, MI; code no. LM115.
Reason
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
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.
Distribution
Illinois.
Quantity
750