—#173229

Product

Sheridan/CF Novaplus 7.0 mm, Product Code 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: Lot 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

This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the Endotracheal tube.

Root cause (FDA determination)

Process control

Action the firm took

Teleflex sent an Urgent Medical Device Recall letter dated May 24, 2019 to customers. The letter identified the affected product, problem and actions to be taken. The letter directed customers to discontinue use, quarantine the product, and contact Teleflex for return of the product. Distributors were directed to notify their customers and request the customer return the recalled products to them for consolidation and subsequent return to Teleflex.. 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: Worldwide - US Nationwide Distribution

Timeline

Recall initiated: 2019-05-24
Posted by FDA: 2019-06-19
Terminated: 2022-02-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #173229. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.