Recall Z-1686-2019 ยท BTR Tube, Tracheal (W/Wo Connector)
Teleflex Medical
RUSCH LASERTUBE (Rubber), Order No. : 102004-000080, REF 102004, SIZE I.D. mm 8,0
| Date | Apr 1, 2019 |
| Status | Terminated |
| Reason | The firm received reports indicating that the laser guard foil partially separated and/or slightly detached at the edges. |
| Root cause | Process control |
| Action | The firm initiated the recall by letter on 04/01/2019. The letter stated reason for the recall and requested the return of the recalled units. Distributors were directed to collect the recalled units from their customers, consolidate them, and complete and return the acknowledgement form. The recalled units will be returned. |
| Quantity | 2325 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K935842 | RUSCH LASERTUBUS/RUSCH LASER RESISTANT CUFFED WITH MURPHY EYE Rusch, Inc., May 23, 1995 |