FDA Device recall Z-2318-2019
Sheridan/HVT Novaplus: a) 7.0 mm, REF V5-10314 b) 7.5 mm, REF V5-10315 c) 8.0 mm, REF V5-10316 d) 8.5 mm, REF V5-10317 Product Usage: Trach…
- FDA Device
- Class I
- terminated
- Published 2019-09-18
On 2019-09-18 the FDA classified a Class I recall of Sheridan/HVT Novaplus: a) 7.0 mm, REF V5-10314 b) 7.5 mm, REF V5-10315 c) 8.0 mm, REF V5-10316 d) 8.5 mm, REF V5-10317 Product Usage: Trach… by Teleflex Medical, citing reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). Disconnection from the….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2318-2019 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2019-07-30 |
| Published | 2019-09-18 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Teleflex Medical |
| Distribution | US |
Product
Sheridan/HVT Novaplus: a) 7.0 mm, REF V5-10314 b) 7.5 mm, REF V5-10315 c) 8.0 mm, REF V5-10316 d) 8.5 mm, REF V5-10317 Product Usage: Tracheal tube/airway management
Reason
Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). Disconnection from the breathing circuit may result in insufficient oxygenation, requiring medical intervention.
Identifiers
| code_info | a) 7.0 mm, REF V5-10314 Batch numbers: 73J1600387 73J1600388 73K1600157 73K1600603 73K1600604 73K1600736 73L160…a) 7.0 mm, REF V5-10314 Batch numbers: 73J1600387 73J1600388 73K1600157 73K1600603 73K1600604 73K1600736 73L1600367 73L1600368 73L1600502 73L1600870 73M1600165 73M1600270 73A1700121 73A1700122 73B1700322 73B1700428 73C1700426 73C1700576 73C1700577 73C1700702 73C1700703 73E1700106 73E1700107 73E1700108 73E1700239 73F1700560 73G1700147 73G1700148 73G1700302 73G1700303 73G1700623 73G1700624 73H1700055 73H1700497 73H1700568 73H1700628 73J1700309 73K1700086 73K1700087 73K1700616 73A1800296 73A1800430 73B1800218 73B1800372 73B1800373 73B1800374 73B1800512 73B1800513 73C1800373 73C1800574 73C1800575 73D1800656 73D1800657 73E1800580 73E1800581 73E1800809 73F1800723 73G1800107 73H1800205 73H1800456 73H1800457 73H1800759 73H1800760 73J1800120 73J1800534 73J1800697 b) 7.5 mm, REF V5-10315 Batch numbers: 73J1600389 73J1600580 73J1600581 73K1600158 73L1600260 73L1600518 73L1600672 73M1600268 73A1700289 73A1700290 73A1 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2318-2019%22
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