BEUDAMED
    FDA Recall Terminated

    Hudson RCI Sheridan/CF: a) 3.0 mm, REF 5-10106, REF 5-10206 b) 3.5 mm, REF 5-10107 c) 4.0 mm, REF 5-10108, REF 5-10208 d) 4.5 mm, REF 5-10109 e) 5.0 mm, REF 5-10110, REF 5-10210 f) 5.5 mm, REF 5-10111 g) 6.0 mm, REF 5-10112, REF 5-10212 h) 6.5 mm, REF 5-10113, REF 5-10213 I) 7.0 mm, REF 5-10114, REF 5-10214 j) 7.5 mm, REF V5-10115, REF 5-10115, REF 5-10215 k) 8.0 mm, REF 5-10116, REF 5-10216, REF V5-10116 l) 8.5 mm, REF 5-10117, REF 5-10217 m) 9.0 mm, REF 5-10118, REF5-10218 n) 9.5 mm, REF 5-10119 o) 10.0 mm, REF 5-10120, REF 5-10220 Product Usage: Tracheal tube/airway management

    Recall: Z-2312-2019 · Initiated July 30, 2019

    Recall

    Recall Number
    Z-2312-2019
    Event Number
    83461
    Firm
    Teleflex Medical
    FEI Number
    3005747797
    Product Code
    BTR
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    July 30, 2019
    Posted
    September 9, 2019
    Terminated
    February 15, 2022
    Address
    3015 Carrington Mill Blvd, Morrisville, NC, 27560-5437

    Description

    Hudson RCI Sheridan/CF: a) 3.0 mm, REF 5-10106, REF 5-10206 b) 3.5 mm, REF 5-10107 c) 4.0 mm, REF 5-10108, REF 5-10208 d) 4.5 mm, REF 5-10109 e) 5.0 mm, REF 5-10110, REF 5-10210 f) 5.5 mm, REF 5-10111 g) 6.0 mm, REF 5-10112, REF 5-10212 h) 6.5 mm, REF 5-10113, REF 5-10213 I) 7.0 mm, REF 5-10114, REF 5-10214 j) 7.5 mm, REF V5-10115, REF 5-10115, REF 5-10215 k) 8.0 mm, REF 5-10116, REF 5-10216, REF V5-10116 l) 8.5 mm, REF 5-10117, REF 5-10217 m) 9.0 mm, REF 5-10118, REF5-10218 n) 9.5 mm, REF 5-10119 o) 10.0 mm, REF 5-10120, REF 5-10220 Product Usage: Tracheal tube/airway management

    Reason

    Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). Disconnection from the breathing circuit may result in insufficient oxygenation, requiring medical intervention.

    Action

    Teleflex sent an Urgent Medical Device Recall Notification letter dated July 30, 2019 to affected customers. The letter explains the problem and requests the consignee discontinue use and quarantine of any of the recalled products then to notify Teleflex. The firm is requesting the return of the affected products. For questions, contact your local sales representative or Customer Service at 1-866-396-2111.

    Distribution

    US Nationwide Distribution

    Quantity

    1805730 units