Recall Z-1124-2015— Teleflex, Inc.
Class II · Terminated
Class II FDA medical device recall by Teleflex, Inc., initiated 2014-12-12, terminated 2015-07-30. It names one FDA 510(k) clearance: K990619. Product: R¿SCH 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.. 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..
- Recalling firm
- Teleflex, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-12-12
- Terminated
- 2015-07-30
- Firm location
- Wayne, PA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
R¿SCH 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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.