RUSCH Slick Set Cuffed Endotracheal Tubes Recalled for Improper Cuff Inflation
Teleflex Medical Europe Ltd. is recalling RUSCH Slick Set Cuffed Endotracheal Tubes because the cuff can inflate while the pilot balloon remains flat, potentially affecting airway pressure monitoring.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall with no reported illnesses or injuries. However, the defect involves potential failure in airway management monitoring, meeting the criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Teleflex Medical Europe Ltd. is recalling RUSCH Slick Set Cuffed Endotracheal Tubes and Stylet Sets distributed nationwide. The recall affects multiple reference numbers (170050 through 170095) with specific lot numbers identified for each product variant. Approximately 32,410 units have been distributed.
The firm received reports indicating that the endotracheal tube cuff could be inflated while the pilot balloon remained flat. The pilot balloon is designed to reflect cuff inflation status, and this malfunction could prevent proper monitoring of cuff pressure during use.
Healthcare facilities and providers using affected lots should discontinue use and contact Teleflex Medical Europe Ltd. for instructions on product return or replacement. Anyone with questions about whether they have affected product should consult the detailed lot number list provided by the manufacturer.
The recalled product
- Product
- 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
- Manufacturer
- Teleflex Medical Europe Ltd
- Hazard
- Affected units
- 32,410
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Teleflex Medical Europe Ltd under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · Teleflex Medical Europe Ltd
See all →- HighRUSCH Endotracheal Tubes Recalled for Potential Cuff Inflation Malfunction
FDA (Devices) · 2021-08-25
- HighRUSCH Flexi-Set Endotracheal Tube Cuff May Inflate Without Pilot Balloon Response
FDA (Devices) · 2021-08-25
- HighRUSCH Endotracheal Tube Cuff Inflation Malfunction Without Pilot Balloon Indication
FDA (Devices) · 2021-08-25
- HighTeleflex Universal Shears Recalled Due to Handle Melting During Sterilization
FDA (Devices) · 2018-07-04
- ModerateTeleflex Laryngo-Tracheal Mucosal Atomization Device Recalled for Labeling Defects
FDA (Devices) · 2018-05-09
Same hazard · cuff malfunction
See all →- HighTeleflex Endotracheal Tubes Recalled for Potential Cuff and Balloon Dysfunction
FDA (Devices) · 2023-02-01