ClearanceBrief
Recall Z-1956-2019 ยท BTR Tube, Tracheal (W/Wo Connector)

Centurion Medical Products Corporation

Sheridan Endotracheal Tube contained inside Centurion kit code TC7855.

DateJul 30, 2019 (initiated Jun 7, 2019)
StatusTerminated
ReasonCenturion is conducting a sub-recall for Teleflex Sheridan branded Endotracheal Tracheal Tubes due to increased incidence of Sheridan connector becoming disconnected from Endotracheal Tube.
Root causeDevice Design
ActionOn June 7, 2019, Centurion notified Medline (the distributor) that they were conducting a recall via an Urgent Product Recall Notice. Medline was instructed to cease further distribution and to notify any customers who received this product. On June 14, 2019, Medline informed its customer of the recall via a letter titled "CENTURION MEDICAL PRODUCT SUB-RECALL*** IMMEDIATE ACTION REQUIRED". REQUIRED ACTION FOR CUSTOMERS: 1. Immediately check your stock for the affected item number and the affected lot number listed on the attachment. Quarantine all affected product. 2. Please return the
Quantity80 kits
DistributionDistributed to one account in Arkansas.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K091761TELEFLEX ISIS HVT TRACHEAL TUBE, CUFFED, WITH SUBGLOTTIC SECRETION SUCTION PORT
Teleflexmedical, Inc., Oct 29, 2009
K822082SHERIDAN/HVT,CF, UNCUFFED
Sheridan Catheter Corp., Aug 10, 1982