Agency classClass IIOur severity:High FDA (Devices)·Z-2319-2021·Announced 2021-08-25

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.

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: 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
Category: Medical Device — Airway Management
Hazard: cuff-malfunction
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 →

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 Flexi-Set Endotracheal Tube Cuff May Inflate Without Pilot Balloon Response
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 · cuff malfunction