Recall Z-1431-06 ยท BSR Stylet, Tracheal Tube
Nellcor Puritan Bennett
Mallinckrodt Satin-Slip Intubation Stylet, 6 Fr., single use, Model number 85863,shipped in cases of 20
| Date | Aug 24, 2006 (initiated Jul 12, 2006) |
| Status | Terminated |
| Reason | Product's outer sheath material may separate from the wire interior during use and may lodge in the endotracheal tube or enter the patient's airway and interfere with ventilation. |
| Root cause | Other |
| Action | The firm has issued notification letters via USPS certified mail with return receipt, requesting that the recipients who have further distributed the product forward a copy of that letter. The firm intends to contact non-responding companies beginning 30 days after the initial notification is sent. |
| Quantity | 30,366 cases of 20 units per case were distributed worldwide |
| Distribution | The product has been distributed to 454 consignees throughout the United States, Guam and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.