Recall Z-2826-2018 ยท BSY Catheters, Suction, Tracheobronchial
Vyaire Medical
The Tri-Flo Subglottic Suction System
| Date | Aug 21, 2018 (initiated Jun 20, 2018) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process control |
| Action | 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 f |
| Quantity | 2150 Units Total |
| Distribution | Domestic Distribution: AZ, CA, CT, FL, GA, IA, IL, IN, MA, MD, MN, NJ, OH, OK, SD, TX, WA, WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.