FDA Device recall Z-2312-2019
Hudson RCI Sheridan/CF: a) 3.0 mm, REF 5-10106, REF 5-10206 b) 3.5 mm, REF 5-10107 c) 4.0 mm, REF 5-10108, REF 5-10208 d) 4.5 mm, REF 5-101…
- FDA Device
- Class I
- terminated
- Published 2019-09-18
On 2019-09-18 the FDA classified a Class I recall of Hudson RCI Sheridan/CF: a) 3.0 mm, REF 5-10106, REF 5-10206 b) 3.5 mm, REF 5-10107 c) 4.0 mm, REF 5-10108, REF 5-10208 d) 4.5 mm, REF 5-101… 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-2312-2019 |
| 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/CF: a) 3.0 mm, REF 5-10106, REF 5-10206 b) 3.5 mm, REF 5-10107 c) 4.0 mm, REF 5-10108, REF 5-10208 d) 4.5 mm, REF 5-10109 e) 5.0 mm, REF 5-10110, REF 5-10210 f) 5.5 mm, REF 5-10111 g) 6.0 mm, REF 5-10112, REF 5-10212 h) 6.5 mm, REF 5-10113, REF 5-10213 I) 7.0 mm, REF 5-10114, REF 5-10214 j) 7.5 mm, REF V5-10115, REF 5-10115, REF 5-10215 k) 8.0 mm, REF 5-10116, REF 5-10216, REF V5-10116 l) 8.5 mm, REF 5-10117, REF 5-10217 m) 9.0 mm, REF 5-10118, REF5-10218 n) 9.5 mm, REF 5-10119 o) 10.0 mm, REF 5-10120, REF 5-10220 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 5-10106 Batch numbers: 73L1600638 73L1600825 73M1600121 73A1700079 73C1700394 73D1700234 73D1700235 73D…a) REF 5-10106 Batch numbers: 73L1600638 73L1600825 73M1600121 73A1700079 73C1700394 73D1700234 73D1700235 73D1700436 73E1700214 73E1700450 73F1700366 73G1700211 73G1700579 73H1700309 73H1700461 73H1700583 73H1700768 73J1700119 73J1700585 73K1700245 73K1700718 73L1700302 73L1700654 73M1700232 73A1800276 73A1800428 73B1800112 73B1800472 73B1800614 73C1800332 73D1800120 73D1800446 73E1800373 73E1800775 73G1800111 73H1800174 73H1800711 73J1800313 73J1800492 73K1800151 73K1800320 73K1800356 73K1800708 73L1800210 73L1800386 73M1800158 REF 5-10206 Batch numbers: 73H1700470 73J1700455 73L1700647 73B1800338 73F1800704 73K1800012 73K1800364 b) REF 5-10107 Batch numbers: 73K1600124 73K1600348 73K1600560 73K1600718 73L1600480 73L1600639 73L1600826 73A1700080 73A1700241 73C1700395 73C1700538 73C1700670 73D1700404 73E1700215 73E1700451 73F1700139 73F1700367 73F1700695 73G1700212 73G1700400 73G1700580 73H1700029 73H |
|---|
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-2312-2019%22
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