Recall Z-1876-2024 ยท BTR Tube, Tracheal (W/Wo Connector)
MEDLINE INDUSTRIES, LP - Northfield
Medline Sub-G Endotracheal Tube with Subglottic Suctioning: (1) REF DYNJ18860, Polyurethane Cuff 6.0 mm ID; (2) REF DYNJ18865, Polyurethane Cuff 6.5 mm ID; (3) REF DYNJ18870, Polyurethane Cuff 7.0 mm ID; (4) REF DYNJ18875, Polyurethane Cuff 7.5 mm ID; (5) REF DYNJ18880, Polyurethane Cuff 8.0 mm ID; and (6) REF DYNJ18885, Polyurethane Cuff 8.5 mm ID. Medline SubG Endotracheal Tube with Subglottic
| Date | May 28, 2024 (initiated Feb 26, 2024) |
| Status | Open, Classified |
| Reason | Complaints have been received that the device inflation tube detached and/or tore from the main tube, resulting in potential moisture buildup, loss of pressure, or inability to inflate. There were also reports the suction pump is difficult to connect or detaches during use. |
| Root cause | Under Investigation by firm |
| Action | The recalling firm issued letters via email and first class mail on 2/26/2024. The recall letter informed the customer the recall was being conducted for specific items and lots of SubG Endotracheal Tube with Subglottic Suction due to receiving complaints that the inflation tube detached and/or tore from the main tube. There had also been reports indicating the suction pump is difficult to connect or detaches during use. The potential product impact was also provided. Affected product could be destroyed for credit and no product was to be returned. Required actions were provided: 1.Immed |
| Quantity | 168,632 tubes and 13,092 kits |
| Distribution | Distribution was nationwide. There was government/military distributon. Foreign distribution was made to San Salvador and United Arab Emirates. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110269 | WELL LEAD ENDOTRACHEAL TUBE WITH EVACUATION LUMEN-ORAL Well Lead Medical Co., Ltd., Aug 26, 2011 |