CLASS II Device recall · Reported 25 Aug 2021 · FDA Enforcement Report
Rusch Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal recalled
Teleflex Medical Europe is recalling Rusch Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, distributed nationwide in the US. The recall was initiated on 16 Jul 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2319-2021
- FDA event ID
- 88353
- Recalling firm
- Teleflex Medical Europe, Athlone, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Jul 2021
- FDA classified
- 19 Aug 2021
- Reported
- 25 Aug 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 16 Jul 2021 | Recall initiated by company | |
| 19 Aug 2021 | Classified by FDA | +34 days |
| 25 Aug 2021 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The firm received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat.
Product as listed by the FDA
RUSCH Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 170050 b) 170055 c) 170060 d) 170065 e) 170070 f) 170075 g) 170080 h) 170085 i) 170090 j) 170095
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
The firm received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat.
Which lots are affected?
a) 170050, Lot Numbers: KME20K2551, KME20L1089, KME20L2371, KME21A2064, KME21B2498, KME21C0488 b) 170055, Lot Numbers: KME20K0936, KME20K2587, KME20L1469, KME20L2378, KME21A0383, KME21A1901, KME21B2682, KME21C2708 c) 170060, Lot Numbers: KME20L1487, KME20L2379, KME20M0494, KME21A0384, KME21A1482, KME21C0293 d) 170065, Lot Numbers: KME20K0938, KME20K2623, KME20L0487, KME20L1705, KME20M1578, KME20M1751, KME20M2709, KME21A0385, KME21A1812, KME21B1670, KME21B2499, KME21B2500, KME21C1592, KME21C2266, KME21C2504, KME21C2706, KME21D1043 e) 170070, Lot Numbers: KME20K2544, KME20L0053, KME20L0055, KME20L0942, KME20L2372, KME20M0381, KME20M0665, KME20M1103, KME20M1754, KME20M1755, KME21A0893, KME21A2264, KME21B1074, KME21B1075, KME21C0463, KME21C0464, KME21C1027, KME21C1422, KME21C1592, KME21C2266, KME21C2504, KME21C2706, KME21D1043 f) 170075, Lot Numbers: KME20K1352, KME20L1132, KME20M0033, KME20M0382, KME20M1149, KME20M1225, KME20M1227, KME20M1537, KME20M2881, KME20M2882, KME21A0824, KME21A1161, KME21A1813, KME21B0813, KME21C0212, KME21C0213, KME21C1594, KME21C1895, KME21C2855, KME21C3294, KME21C3295 g) 170080, Lot Numbers: KME20L0396, KME20L1278, KME20L1279, KME20L2830, KME20M0847 , KME21A0386, KME21A2800, KME21A2801, KME21B1245, KME21B1752, KME21B2156, KME21C0465, KME21C0533, KME21C2826 h) 170085, Lot Numbers: KME20L0398, KME20L2376, KME20M3247, KME21A1894, KME21C0298, KME21C2385 i) 170090, Lot Numbers: KME20L0625 j) 170095, Lot Numbers: KME20M0384, KME21B0407
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 88353| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Rusch Endotracheal Tube oral/nasal Murphy Eye, High Volume recalled | Teleflex Medical Europe | Other | Nationwide | |
| CLASS II | Rusch Endotracheal Tube oral/nasal Magill, High Volume recalled | Teleflex Medical Europe | Other | Nationwide | |
| CLASS II | Rusch Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal recalled | Teleflex Medical Europe | Other | Nationwide |
More recalls from Teleflex Medical Europe
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Rusch Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal recalled | Teleflex Medical Europe | Other | Nationwide |
| Device | CLASS II | Rusch Endotracheal Tube oral/nasal Magill, High Volume recalled | Teleflex Medical Europe | Other | Nationwide |
| Device | CLASS II | Rusch Endotracheal Tube oral/nasal Murphy Eye, High Volume recalled | Teleflex Medical Europe | Other | Nationwide |
| Device | CLASS II | Teleflex Medical Pilling(R) Universal Shears 7 1/2" recalled | Teleflex Medical Europe | Foreign Material | Nationwide |
| Device | CLASS II | Teleflex Medical Lma(TM) MADgic(TM) Laryngo-tracheal recalled | Teleflex Medical Europe | Packaging Defects | TX |
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