Z-2826-2018 Class I Terminated
FDA device recall Z-2826-2018 was initiated by Vyaire Medical on Jun 20, 2018 and is designated Class I. 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… The recall status is terminated (terminated Jul 28, 2020). Affected quantity: 2150 Units Total.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 29, 2018
- Initiation Date
- Jun 20, 2018
- Termination Date
- Jul 28, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2150 Units Total
Product Description
The Tri-Flo Subglottic Suction System
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.
Distribution Pattern
Domestic Distribution: AZ, CA, CT, FL, GA, IA, IL, IN, MA, MD, MN, NJ, OH, OK, SD, TX, WA, WI.
Code Information
Part number: CM28010; Lot/Serial Numbers: 0001158835 , 0001158836, 0001158837, 0001185564, 0001194114 , 0004008255, 0004008256.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2826-2018
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026