—#175360

Product

Sheridan/CF Novaplus 7.0 mm, REF V5-10114 Product Usage: Tracheal tube/airway management

FDA product code: BTR — Tube, Tracheal (W/Wo Connector)
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K822082
Affected lot / code info: Batch numbers: 73K1600156 73K1600735 73L1600501 73A1700120 73B1700321 73C1700425 73D1700630 73E1700504 73G1700146 73H1700053 73J1700307 73K1700085 73B1800223 73B1800371 73C1800372 73D1800655 73E1800579 73G1800627 73H1800203 73H1800429 73H1800758 73J1800118 73J1800696

Why it was recalled

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.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Teleflex Medical
Address: 3015 Carrington Mill Blvd, Morrisville, North Carolina 27560-5437

Distribution

Distribution pattern: US Nationwide Distribution

Timeline

Recall initiated: 2019-07-30
Posted by FDA: 2019-09-09
Terminated: 2022-02-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #175360. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.