FDA Device recall Z-2314-2019
Hudson RCI Sheridan Preformed: a) 3.0 mm, REF 5-22006, REF 5-22106 b) 3.5 mm, REF 5-22007, REF 5-22107 c) 4.0 mm, REF 5-22008, REF 5-22108,…
- FDA Device
- Class I
- terminated
- Published 2019-09-18
On 2019-09-18 the FDA classified a Class I recall of Hudson RCI Sheridan Preformed: a) 3.0 mm, REF 5-22006, REF 5-22106 b) 3.5 mm, REF 5-22007, REF 5-22107 c) 4.0 mm, REF 5-22008, REF 5-22108,… 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-2314-2019 |
| 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 Preformed: a) 3.0 mm, REF 5-22006, REF 5-22106 b) 3.5 mm, REF 5-22007, REF 5-22107 c) 4.0 mm, REF 5-22008, REF 5-22108, REF 5-22208 d) 4.5 mm, REF 5-22009, REF 5-22109, REF 5-22209 e) 5.0 mm, REF 5-22010, REF 5-22110, REF 5-22210 f) 5.5 mm, REF 5-22011, REF 5-22111, REF 5-22211 g) 6.0 mm, REF 5-22212, REF 5-22312, REF 5-22112 h) 6.5 mm, REF 5-22313, REF 5-22213, REF 5-22013, REF 5-22113 i) 7.0 mm, REF 5-22214, REF 5-22314, REF 5-22014, REF 5-22114 j) 7.5 mm, REF 5-22215, REF 5-22315 k) 8.0 mm, REF 5-22216, REF 5-22316 l) 8.5 mm, REF 5-22217 m) 9.0 mm, REF 5-22218 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 5-22006 Batch numbers: 73E1700489 73G1700128 73K1700075 73L1700176 73C1800361 73E1800241 73F1800556 73…a) REF 5-22006 Batch numbers: 73E1700489 73G1700128 73K1700075 73L1700176 73C1800361 73E1800241 73F1800556 73G1800589 73G1800932 73L1800417 73L1800418 73M1800194 73M1800195 REF 5-22106 Batch numbers: 73E1700719 73M1700260 73E1800567 73J1800524 73K1800731 b) REF 5-22007 Batch numbers: 73L1600002 73K1700426 73A1800460 73D1800648 73E1800565 REF 5-22107 Batch numbers: 73L1600864 73F1700166 73E1800088 73K1800772 c) REF 5-22008 Batch numbers: 73C1700413 73F1700164 73G1700129 73J1700300 73A1800461 73B1800362 73F1800183 REF 5-22108 Batch numbers: 73K1600590 73M1600152 73A1700110 73D1700629 73F1700028 73B1800133 73E1800089 73G1800933 73J1800100 REF 5-22208 Batch numbers: 73L1600360 73A1700112 73D1700258 73F1700032 73F1700725 73G1700605 73H1700786 73J1700478 73K1700275 73K1700740 73L1700508 73M1700263 73A1800316 73A1800816 73B1800493 73C1800365 73D1800147 73E1800091 73E1800569 73F1800557 73H1800679 |
|---|
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-2314-2019%22
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