FDA Device recall Z-1010-2023
Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal
- FDA Device
- Class II
- ongoing
- Published 2023-02-01
On 2023-02-01 the FDA classified a Class II recall of Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal by Teleflex, citing potential for pilot balloon non-inflation or cuff non-deflation.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1010-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-12-08 |
| Published | 2023-02-01 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Teleflex |
| Distribution | US |
Product
Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal. Intended for patients requiring endotracheal intubation
Reason
Potential for pilot balloon non-inflation or cuff non-deflation.
Identifiers
| code_info | a. Product Code: 170060, Batch Number: KME21E1411, UDI: (01)04026704319558(17)260428(10)KME21E1411; b. Product Code:…a. Product Code: 170060, Batch Number: KME21E1411, UDI: (01)04026704319558(17)260428(10)KME21E1411; b. Product Code: 170070, Batch Number (UDI): KME21D1430 ((01)04026704319572(17)260328(10)KME21D1430), KME21E1290 ((01)04026704319572(17)260428(10)KME21E1290); c. Product Code: 170075, Batch Number: KME21D1785, UDI:(01)04026704319589(17)260328(10)KME21D1785; d. Product Code: 170080, Batch Number (UDI): KME21D1204 ((01)04026704319596(17)260328(10)KME21D1204), KME21E1287 ((01)04026704319596(17)260428(10)KME21E1287); e. Product Code: 170085, Batch Number: KME21E1296, UDI:(01)4026704319602(17)260428(10)KME21E1296; f. Product Code: 170090, Batch Number: KME21E1232, UDI: (01)4026704319619(17)260428(10)KME21E1232 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1010-2023%22
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