Recall Z-1956-2019— Centurion Medical Products Corporation
Class I · Terminated
Class I FDA medical device recall by Centurion Medical Products Corporation, initiated 2019-06-07, terminated 2020-07-28. It names 2 FDA 510(k) clearances: K091761, K822082. Product: Sheridan Endotracheal Tube contained inside Centurion kit code TC7855.. Reason: Centurion is conducting a sub-recall for Teleflex Sheridan branded Endotracheal Tracheal Tubes due to increased incidence of Sheridan connector becoming disconnected from Endotracheal Tube..
- Recalling firm
- Centurion Medical Products Corporation
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2019-06-07
- Terminated
- 2020-07-28
- Firm location
- Williamston, MI, United States
510(k) clearances named in this recall
2 on FDA's record- K091761 — TELEFLEX ISIS HVT TRACHEAL TUBE, CUFFED, WITH SUBGLOTTIC SECRETION SUCTION PORT
- K822082 — SHERIDAN/HVT,CF, UNCUFFED
K-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
Sheridan Endotracheal Tube contained inside Centurion kit code TC7855.
Reason for recall
Centurion is conducting a sub-recall for Teleflex Sheridan branded Endotracheal Tracheal Tubes due to increased incidence of Sheridan connector becoming disconnected from Endotracheal Tube.
Data sourced from openFDA. This site is unofficial and independent of the FDA.