Agency classClass IIOur severity:High FDA (Devices)·Z-2320-2021·Announced 2021-08-25

RUSCH Flexi-Set Endotracheal Tube Cuff May Inflate Without Pilot Balloon Response

Teleflex Medical Europe Ltd is recalling RUSCH Flexi-Set Cuffed Endotracheal Tubes nationwide because the cuff can inflate while the pilot balloon remains flat, preventing proper verification of cuff status.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: This is an FDA Class II medical device recall involving a functional malfunction in a critical airway management device. No illnesses, injuries, or deaths are reported. Per the severity rubric, when no harm has been reported and the hazard is functional rather than resulting in direct injury, the maximum score is 3 (High).

Plain-English summary

Teleflex Medical Europe Ltd is recalling the RUSCH Flexi-Set Cuffed Endotracheal Tube and Stylet Set for oral and nasal use. Approximately 155,030 units have been distributed nationwide in clinical settings.

The company received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat. This represents a malfunction where the indicator may not reflect the actual cuff status during use.

Healthcare providers using affected products should review the recall notice for specific lot numbers and contact Teleflex Medical Europe Ltd for guidance on discontinuation and replacement of affected units.

The recalled product

Product: RUSCH Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 504550 b) 504555 c) 504560 d) 504565 e) 504570 f) 504575 g) 504580 f) 504585 g) 504590
Manufacturer: Teleflex Medical Europe Ltd
Category: Medical Device — Airway Management
Hazard: device-malfunction
monitoring-defect
Affected units: 155,030

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) 504550
Lot Numbers: KME20K0001
KME20K0467
KME20K1581
KME20L0618
KME20L1090
KME20L2027
KME20M0019
KME21A2076
KME21A2787
KME21B1140
KME21C0059
KME21C2363 b) 504555
Lot Numbers: KME20K0765
KME20K0766
KME20K0935
KME20K1582
KME20L0619
KME20L1857
KME20L2028

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 →

Same manufacturer · Teleflex Medical Europe Ltd

See all →

High
RUSCH Endotracheal Tubes Recalled for Potential Cuff Inflation Malfunction
FDA (Devices) · 2021-08-25
High
RUSCH Slick Set Cuffed Endotracheal Tubes Recalled for Improper Cuff Inflation
FDA (Devices) · 2021-08-25
High
RUSCH Endotracheal Tube Cuff Inflation Malfunction Without Pilot Balloon Indication
FDA (Devices) · 2021-08-25
High
Teleflex Universal Shears Recalled Due to Handle Melting During Sterilization
FDA (Devices) · 2018-07-04
Moderate
Teleflex Laryngo-Tracheal Mucosal Atomization Device Recalled for Labeling Defects
FDA (Devices) · 2018-05-09

Same hazard · device malfunction