Recall Z-1124-2015 ยท BTR Tube, Tracheal (W/Wo Connector)
Teleflex, Inc.
RSCH Curved Reinforced Endotracheal Tube: Rusch Reinforced Endotracheal Tube is designated for oral or nasal intubation and are indicated for airway management. The product may be used to reduce the potential for kinking whenever an unusual positioning of the head or neck is required following intubation.
| Date | Feb 17, 2015 (initiated Dec 12, 2014) |
| Status | Terminated |
| Reason | Teleflex Medical has issued an advisory notification for the RUSCH Curved Reinforced Endotracheal Tube because of a discrepancy between the labeled cuff diameter and the actual cuff diameter. The actual product cuff diameter meets required specification. |
| Root cause | Labeling mix-ups |
| Action | Teleflex Medical sent an Urgent Medical Device Notification dated December 12, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please provide this Advisory Notice to all those who need to be aware of it within your organization. Please consider, clinicians, risk managers, supply chain/distribution centres, etc. in the circulation of this notice. There is no further action required. Clinical recommendation with regard to patient use is to continue the standard clinical practice of basing ET tube selection based |
| Quantity | 2,292,361 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K990619 | RUSCH REINFORCED ENDOTRACHEAL (OR TRACHEAL) TUBE- CUFFED AND UNCUFFED MURPHY/MAGILL, STERILE Rusch Intl., Aug 3, 1999 |