Recall Z-2370-2015— Teleflex Medical
Class I · Terminated
Class I FDA medical device recall by Teleflex Medical, initiated 2015-06-01, terminated 2018-04-16. FDA's recall record names no specific 510(k) clearance for this event. Product: HUDSON RCI, Sheridan, SHER-I-SWIV and SHER-I-SWIV/FO Double Swivel, Rx Only, Sterile. Used temporarily to make rigid a flexible tracheal tube to aid its insertion into a patient.. Reason: The double swivel connector may crack or separate on the endobronchial tube..
- Recalling firm
- Teleflex Medical
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2015-06-01
- Terminated
- 2018-04-16
- Firm location
- Research Triangle Park, NC, United States
Product description
HUDSON RCI, Sheridan, SHER-I-SWIV and SHER-I-SWIV/FO Double Swivel, Rx Only, Sterile. Used temporarily to make rigid a flexible tracheal tube to aid its insertion into a patient.
Reason for recall
The double swivel connector may crack or separate on the endobronchial tube.
Data sourced from openFDA. This site is unofficial and independent of the FDA.