Hudson RCI Sheridan Preformed: a) 3 — Class I medical device recall Z-2314-2019
Terminated recall by Teleflex Medical, reported 2019-09-18, distributed nationwide. Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming
| Recall number | Z-2314-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teleflex Medical, Morrisville, NC, United States |
| Recall initiated | 2019-07-30 |
| Classified | 2019-09-09 |
| Reported by FDA | 2019-09-18 |
| Terminated | 2022-02-15 |
| Distributed | Nationwide (US) |
| Quantity | 278,142 units |
| Lot numbers | 73A1700109, 73A1700110, 73A1700111, 73A1700112, 73A1700114, 73A1700115, 73A1700116, 73A1700117, 73A1700274, 73A1700275, 73A1700276, 73A1700277, 73A1700278, 73A1700279, 73A1700736, 73A1700737, 73A1700738, 73A1700739, 73A1800020, 73A1800022, 73A1800023, 73A1800024, 73A1800025, 73A1800044, 73A1800066, 73A1800067, 73A1800300, 73A1800301, 73A1800302, 73A1800303, 73A1800304, 73A1800316, 73A1800448, 73A1800449, 73A1800450, 73A1800451, 73A1800452, 73A1800453, 73A1800454, 73A1800455 and 460 more |
| Model numbers | 5-22006, 5-22007, 5-22008, 5-22009, 5-22010, 5-22011, 5-22013, 5-22014, 5-22106, 5-22107, 5-22108, 5-22109, 5-22110, 5-22111, 5-22112, 5-22113, 5-22114, 5-22208, 5-22209, 5-22210, 5-22211, 5-22212, 5-22213, 5-22214, 5-22215 and 8 more |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2314-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.