Teleflex Recalls Rusch Endobronchial Tubes Due to Cuff Seal Failure
Teleflex Medical is recalling Rusch Brochopart endobronchial tubes because the cuff may inflate to one side, preventing a proper seal of the right lung.
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: The recall is classified as FDA Class II. The hazard involves a functional failure of a medical device used in surgical and anesthesia contexts, which poses a risk of harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Teleflex Medical is recalling 63,568 units of Rusch Brochopart and Rusch Brochopart White endobronchial tube sets. These medical devices are indicated for uses associated with oral endobronchial tubes, including thoracic surgery, bronchospirometry, and the administration of endobronchial anesthesia. The endobronchial tube allows for ventilation and selective inflation or deflation of either lung.
The recall was initiated because the product may fail to achieve a seal of the right lung due to the cuff inflating to one side. This defect could compromise the intended function of the device during medical procedures.
The affected products were distributed worldwide, including nationwide distribution in the United States (including Puerto Rico) and numerous international countries. Specific product codes and batch numbers are listed in the structured product information. Healthcare providers and facilities should check their inventory for the specific product codes and batch numbers identified in the recall notice and stop using the affected units.
The recalled product
- Product
- Rusch Brochopart and Rusch Brochopart White The Rush Endobronchial Tube set is indicated for uses commonly associated with oral endobronchial tubes, including, but not limited to, thoracic surgery, bronchospirometry, administration of endobronchial anesthesia, etc. The…
- Manufacturer
- Teleflex Medical
- Affected units
- 63,568
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)
- Product Code - 116200260
- Batch 09LE51
- 10GE31
- 11LE42
- 12DE17
- 12IE37
- 13CT26
- 13DT32
- Product Code - 116200280 - Batch 09HE34
- 09JE41
- 10BE07
- 11HE33
- 11JE41
- 13ET12
- Product Code - 116200350 - Batch 0918M
- 0915M
- 09JE43
- 09JE42
- 0917M
- 11AE03
Distribution
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