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U.S. Department of Health and Human Services

Class 1 Device Recall TriFlo''" Subglottic Suction System

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 Class 1 Device Recall TriFlo''" Subglottic Suction Systemsee related information
Date Initiated by FirmJune 20, 2018
Date PostedAugust 21, 2018
Recall Status1 Terminated 3 on July 28, 2020
Recall NumberZ-2826-2018
Recall Event ID 80508
Product Classification Catheters, suction, tracheobronchial - Product Code BSY
ProductThe Tri-Flo Subglottic Suction System
Code Information Part number: CM28010;  Lot/Serial Numbers: 0001158835 , 0001158836, 0001158837, 0001185564, 0001194114 , 0004008255, 0004008256. 
FEI Number 2050001
Recalling Firm/
Manufacturer		 Vyaire Medical
26125 N Riverwoods Blvd
Mettawa IL 60045-3420
Manufacturer 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.
FDA Determined
Cause 2		Process control
ActionThe 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.
Quantity in Commerce2150 Units Total
DistributionDomestic Distribution: AZ, CA, CT, FL, GA, IA, IL, IN, MA, MD, MN, NJ, OH, OK, SD, TX, WA, WI.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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