Recall Z-1626-2016 ยท BTR Tube, Tracheal (W/Wo Connector)
Stryker Sustainability Solutions
Launcher Guiding Catheter Model #LA6EBU30. Used in the coronary or peripheral vascular system..
| Date | Apr 4, 2016 |
| Status | Terminated |
| Reason | Device packaging may not be sealed. |
| Root cause | Process control |
| Action | Customer notification letter was sent 04/04/2016. The customer was provided the following instructions: Use of the affected lots of the recalled product should be discontinued. A Recall Effectiveness Check Form has been enclosed. Note that the recall is limited to the specific lot number shipped to facility. Once inventory has been checked complete the Recall Effectiveness Check Form. The form needs to be completed even if no affected product is found. Return the completed and signed Recall Effectiveness Check Form utilizing one of the following methods: Return to your local Stryker Susta |
| Quantity | 2 |
| Distribution | US distribution to KY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082520 | SEALGUARD EVAC ENDOTRACHEAL AND ENDOTRACHEAL TUBES Mallinckrodt Medical, Oct 2, 2008 |