Recall Z-0106-2010 ยท BTR Tube, Tracheal (W/Wo Connector)
Centurion Medical Products
Tri-State Hospital Supply Corp., Centurion Healthcare Products, Full Term Meconium Packs, 50, sterile, Tri-State Hospital Supply Corp., Howell, MI; code no. LM115.
| Date | Nov 12, 2009 (initiated Sep 22, 2009) |
| Status | Terminated |
| 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. |
| Root cause | Process control |
| 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. |
| Quantity | 750 |
| Distribution | Illinois. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.