Recall Z-2714-2014— Teleflex Medical
Class I · Terminated
Class I FDA medical device recall by Teleflex Medical, initiated 2014-09-08, terminated 2016-08-16. FDA's recall record names no specific 510(k) clearance for this event. Product: Hudson RCI¿ Pediatric Anesthesia Breathing Circuits, Single Patient Use, Rx Only, Product Usage: To administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Ypiece.. Reason: The pediatric breathing circuits can crack prior to and during use..
- Recalling firm
- Teleflex Medical
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2014-09-08
- Terminated
- 2016-08-16
- Firm location
- Durham, NC, United States
Product description
Hudson RCI¿ Pediatric Anesthesia Breathing Circuits, Single Patient Use, Rx Only, Product Usage: To administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Ypiece.
Reason for recall
The pediatric breathing circuits can crack prior to and during use.
Data sourced from openFDA. This site is unofficial and independent of the FDA.