FDA Device recall Z-1760-2019
Hudson RCI Sheridan: 1) CF 6.0 mm, Product Codes: 5-10112, 5-10212 2) CF 6.5 mm, Product Codes: 5-10113, 5-10213 3) CF 7.0 mm, Product Code…
- FDA Device
- Class I
- terminated
- Published 2019-06-26
On 2019-06-26 the FDA classified a Class I recall of Hudson RCI Sheridan: 1) CF 6.0 mm, Product Codes: 5-10112, 5-10212 2) CF 6.5 mm, Product Codes: 5-10113, 5-10213 3) CF 7.0 mm, Product Code… by Teleflex Medical, citing this voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased incidence of specific lots of the 15 mm Sh….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1760-2019 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2019-05-24 |
| Published | 2019-06-26 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Teleflex Medical |
| Distribution | US |
Product
Hudson RCI Sheridan: 1) CF 6.0 mm, Product Codes: 5-10112, 5-10212 2) CF 6.5 mm, Product Codes: 5-10113, 5-10213 3) CF 7.0 mm, Product Codes: 5-10114, 5-10214 4) CF 7.5 mm, Product Codes: V5-10115, 5-10115, 5-10215 5) CF 8.0 mm, Product Codes: 5-10116, 5-10216, V5-10116 6) CF 8.5 mm, Product Codes: 5-10117, 5-10217 Product Usage: Tracheal tube/airway management
Reason
This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the Endotracheal tube.
Identifiers
| code_info | 1) CF 6.0 mm, Product Codes: a) 5-10112, Lot Numbers: 73J1600560 73J1600743 73K1600130 73K1600565 73L1600008…1) CF 6.0 mm, Product Codes: a) 5-10112, Lot Numbers: 73J1600560 73J1600743 73K1600130 73K1600565 73L1600008 73L1600325 73L1600642 73L1600830 73M1600126 73A1700085 73A1700246 73A1700717 73B1700288 73B1700395 73B1700615 73C1700223 73C1700397 73C1700541 73D1700236 73D1700610 73E1700217 73E1700454 73E1700698 73F1700532 73G1700137 73G1700214 73G1700585 73H1700033 73H1700466 73J1700125 73J1700277 73J1700588 73K1700053 73K1700249 73K1700394 73K1700582 73L1700166 73L1700306 73L1700521 73L1700659 73M1700133 73M1700445 73A1800042 73A1800281 73A1800662 73B1800114 73B1800474 73B1800700 73C1800183 73C1800469 73D1800300 73D1800624 73E1800061 73E1800225 73E1800779 73F1800157 73F1800529 73F1800697 73G1800115 73G1800212 73G1800562 73G1800791 73H1800178 73H1800652 73J1800082 73J1800317 73J1800496 73J1800656 73K1800359 73L1800193 b) 5-10212, Lot Numbers: 73J1600749 73J1800345 73K1800367 2) CF 6.5 mm, Product Codes: a |
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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-1760-2019%22
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