FDA Device recall Z-2315-2019
Hudson RCI Sheridan Uncuffed: a) 2.0 mm, REF 5-10404 b) 2.5 mm, REF 5-10405 c) 3.0 mm, REF 5-10406 d) 3.5 mm, REF 5-10407 e) 4.0 mm, REF 5-…
- FDA Device
- Class I
- terminated
- Published 2019-09-18
On 2019-09-18 the FDA classified a Class I recall of Hudson RCI Sheridan Uncuffed: a) 2.0 mm, REF 5-10404 b) 2.5 mm, REF 5-10405 c) 3.0 mm, REF 5-10406 d) 3.5 mm, REF 5-10407 e) 4.0 mm, REF 5-… 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-2315-2019 |
| 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 Uncuffed: a) 2.0 mm, REF 5-10404 b) 2.5 mm, REF 5-10405 c) 3.0 mm, REF 5-10406 d) 3.5 mm, REF 5-10407 e) 4.0 mm, REF 5-10408 f) 4.5 mm, REF 5-10409 g) 5.0 mm, REF 5-10410 h) 5.5 mm, REF 5-10411 i) 6.0 mm, REF 5-10412 j) 6.5 mm, REF 5-10413 k) 7.0 mm, REF 5-10414 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 5-10404 Batch numbers: 73L1600844 73A1700096 73A1700260 73B1700298 73C1700405 73F1700381 73F1700710 73H…a) REF 5-10404 Batch numbers: 73L1600844 73A1700096 73A1700260 73B1700298 73C1700405 73F1700381 73F1700710 73H1700323 73H1700478 73M1700246 73A1800055 73B1800120 73E1800552 73J1800091 73L1800610 b) REF 5-10405 Batch numbers: 73L1600845 73A1700097 73A1700725 73B1700299 73F1700712 73G1700418 73H1700038 73H1700479 73J1700287 73A1800056 73A1800462 73B1800121 73E1800553 73F1800713 73H1800423 73H1800664 73K1800376 c) REF 5-10406 Batch numbers: 73L1600495 73B1700621 73D1700622 73E1700710 73F1700152 73G1700131 73H1700480 73J1700128 73J1700599 73K1700594 73L1700318 73M1700139 73M1700415 73A1800057 73A1800463 73A1800811 73B1800484 73C1800192 73D1800310 73D1800462 73E1800386 73E1800790 73F1800541 73G1800576 73H1800189 73H1800665 73J1800092 73L1800209 73L1800404 73L1800513 73L1800611 73L1800727 73M1800178 73M1800342 d) REF 5-10407 Batch numbers: 73K1600366 73L1600643 73A1700261 73D1700408 73G1700419 73H1700039 73 |
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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-2315-2019%22
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