FDA Device recall Z-1762-2019
Hudson RCI Sheridan: 1) Preformed 6.0 mm, Product Codes: a) 5-22212, b) 5-22312, c) 5-22112, d) 5-22012, 2) Preformed 6.5 mm, Product Codes…
- 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) Preformed 6.0 mm, Product Codes: a) 5-22212, b) 5-22312, c) 5-22112, d) 5-22012, 2) Preformed 6.5 mm, Product Codes… 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-1762-2019 |
| 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) Preformed 6.0 mm, Product Codes: a) 5-22212, b) 5-22312, c) 5-22112, d) 5-22012, 2) Preformed 6.5 mm, Product Codes: a) 5-22313, b) 5-22213, c) 5-22013, d) 5-22113, 3) Preformed 7.0 mm, Product Codes: a) 5-22214, b) 5-22314, c) 5-22014, d) 5-22114, 4) Preformed 7.5 mm, Product Codes: a) 5-22215, b) 5-22315, 5) Preformed 8.0 mm, Product Codes: a) 5-22216, b) 5-22316, 6) Preformed 8.5 mm, Product Codes: 5-22217 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 | Hudson RCI Sheridan: 1) Preformed 6.0 mm, Product Codes: a) 5-22212, Lot Numbers: 73J1600378 73K1600730 73L160…Hudson RCI Sheridan: 1) Preformed 6.0 mm, Product Codes: a) 5-22212, Lot Numbers: 73J1600378 73K1600730 73L1600665 73M1600158 73B1700049 73B1700313 73C1700416 73D1700643 73F1700034 73F1700171 73F1700728 73G1700609 73H1700341 73J1700481 73J1700681 73K1700431 73L1700179 73L1700511 73M1700267 73A1800302 73A1800450 73B1800138 73C1800551 73D1800150 73E1800570 73F1800345 73H1800196 73J1800290 73K1800186 b) 5-22312, Lot Numbers: 73K1600151 73L1600512 73M1600159 73A1700737 73B1700423 73C1700697 73D1700426 73E1700561 73E1700721 73F1700173 73F1700730 73G1700612 73H1700620 73J1700141 73J1700484 73K1700078 73K1700433 73K1700744 73L1700516 73A1800023 73B1800140 73B1800500 73C1800328 73D1800474 73E1800398 73F1800561 73G1800139 73H1800683 73J1800109 73K1800188 c) 5-22112, Lot Numbers: 73L1600359 73M1600155 73A1700278 73C1700415 73F1700168 73G1700426 73H1700615 73L1700650 73B1800492 73H1800678 73K1800326 73K1800374 |
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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-1762-2019%22
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