The Tri-Flo Subglottic Suction System

FDA device recall Z-2826-2018 · posted 2018-08-21 · Terminated

Recall details

Recalling firm

Vyaire Medical

Reason for recall

Vyaire Medical has discovered potential patient safety risk with associated with the Tri-Flow Subglottic Suction System. The distal soft tip of the catheter has been identified as having the potential to break off during patient use and result in aspiration of a solid foreign body.

Action taken

The firm notified its customers on/about 06/20/2018 via a letter entitled " URGENT: Tri-Flo" Subglottic Suction System RECALL NOTIFICATION". This letter described the affected part, and lot numbers as well as the distribution dates for affected part numbers. The letter described the following actions to be taken by the customer which include: 1) Inspect current inventory on-hand. A 100% physical inventory should immediately be performed to identify and remove the Tri-Flo TM Subglottic Suction Systems (CM28010) from distribution due to the identified potential patient safety risk. 2) If a facility has further distributed affected product, Vyaire states a entity must further notify customers of this URGENT RECALL NOTIFICATION . 3) Return all in-stock inventory affected by this recall by calling Vyaire's Customer Service Support team at 833-3BREATH (833-327-3284) (Option #1) Monday-Friday 7:00 am CST- 5:30 pm CST to obtain a pre-paid shipping Return Goods Authorization (RGA). Requests for credit can be made by providing the original P.O. number for in-stock inventory. 4) Complete the Customer Response Form (Appendix 1) and return to GMB-GLB VSFieldActions@Vyaire.com. The letter also included instructions if an end-user customer/ facility that did not purchase the product directly through Vyaire Medical, to work with the distributor to return or receive credit for in-stock inventory affected by this recall. Any additional questions concerning this voluntary Recall, the firm recommended contacting Lindy Schenning at 1.872.757.0109 or via e-mail at Lindy.Schenning@Vyaire .com.

Root cause

Process control

Status

Terminated

Product code

BSY

Quantity affected

2150 Units Total

Distribution

Domestic Distribution: AZ, CA, CT, FL, GA, IA, IL, IN, MA, MD, MN, NJ, OH, OK, SD, TX, WA, WI.

Date initiated

2018-06-20

Date posted

2018-08-21

Date terminated

2020-07-28

Location

Mettawa, IL