FDA Device recall Z-2316-2019
Hudson RCI Sheridan/HVT: a) 5.0 mm, REF 5-10310 b) 5.5 mm, REF 5-10311 c) 6.0 mm, REF 5-10312 d) 6.5 mm, REF 5-10313 e) 7.0 mm, REF 5-10314…
- FDA Device
- Class I
- terminated
- Published 2019-09-18
On 2019-09-18 the FDA classified a Class I recall of Hudson RCI Sheridan/HVT: a) 5.0 mm, REF 5-10310 b) 5.5 mm, REF 5-10311 c) 6.0 mm, REF 5-10312 d) 6.5 mm, REF 5-10313 e) 7.0 mm, REF 5-10314… 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-2316-2019 |
| 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
Hudson RCI Sheridan/HVT: a) 5.0 mm, REF 5-10310 b) 5.5 mm, REF 5-10311 c) 6.0 mm, REF 5-10312 d) 6.5 mm, REF 5-10313 e) 7.0 mm, REF 5-10314 f) 7.5 mm, REF 5-10315 g) 8.0 mm, REF 5-10316 h) 8.5 mm, REF 5-10317 i) 9.0 mm, REF 5-10318 j) 10.0 mm, REF 5-10320 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) REF 5-10310 Batch numbers: 73K1600356 73L1600336 73L1600486 73L1600836 73M1600132 73B1700134 73C1700227 73…a) REF 5-10310 Batch numbers: 73K1600356 73L1600336 73L1600486 73L1600836 73M1600132 73B1700134 73C1700227 73C1700676 73D1700243 73E1700091 73F1700013 73F1700145 73F1700702 73G1700410 73H1700471 73H1700777 73J1700593 73K1700254 73K1700723 73L1700661 73A1800282 73A1800664 73B1800341 73C1800186 73C1800563 73D1800303 73D1800454 73E1800071 73E1800378 73F1800706 73G1800567 73K1800540 73K1800541 b) REF 5-10311 Batch numbers: 73K1600357 73L1600337 73L1600487 73L1600837 73A1700253 73C1700677 73D1700126 73E1700092 73E1700459 73E1700221 73F1700374 73G1700411 73G1700590 73H1700472 73J1700459 73K1700255 73K1700724 73M1700239 73A1800283 73A1800809 73C1800187 73D1800132 73D1800304 73D1800455 73E1800379 73E1800784 73F1800536 73H1800183 c) REF 5-10312 Batch numbers: 73J1600355 73J1600564 73J1600751 73K1600137 73K1600571 73L1600138 73L1600338 73L1600488 73L1600650 73L1600838 73M1600133 73A1700091 73A1700254 73A170072 |
|---|
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-2316-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.